FDA Regulation
The Food and Drug Administration regulates various facets of our daily lives, including the food we eat, the medications we take and the medical devices implanted in our bodies. It’s crucial to know the risks and benefits, in addition to how the FDA functions. We track FDA activity to give you the latest updates on recalls, meetings, hearings and safety investigations.
Top Articles on FDA Regulation
FDA Encourages Use of Disposable Duodenoscopes
Tess Francke · November 18, 2019
Traditional duodenoscopes may cause infection. The FDA recommends hospitals transition to disposable duodenoscopes and warns against illegal ATP test strips used to determine cleanliness.
FDA RegulationFormer FDA Adviser Draws Attention to Complications With LASIK
Emma Schkloven · November 22, 2019
Dr. Morris Waxler, a retired Food and Drug Administration advisor who voted to approve LASIK in the 1990s, is now calling for the medical device to be removed from the market.
NewsFDA Wants Recall of Zantac and Axid Amid Cancer Concern
Carah Wertheimer · November 5, 2019
Zantac, a commonly used heartburn medication, can contain the carcinogenic toxin NDMA, prompting the FDA to issue a voluntary recall.
FDA Regulation-
FDA Encourages Use of Disposable Duodenoscopes
Tess Francke · November 18, 2019
Traditional duodenoscopes may cause infection. The FDA recommends hospitals transition to disposable duodenoscopes and warns against illegal ATP test strips used to determine cleanliness.
FDA Regulation -
Former FDA Adviser Draws Attention to Complications With LASIK
Emma Schkloven · November 22, 2019
Dr. Morris Waxler, a retired Food and Drug Administration advisor who voted to approve LASIK in the 1990s, is now calling for the medical device to be removed from the market.
News -
FDA Wants Recall of Zantac and Axid Amid Cancer Concern
Carah Wertheimer · November 5, 2019
Zantac, a commonly used heartburn medication, can contain the carcinogenic toxin NDMA, prompting the FDA to issue a voluntary recall.
FDA Regulation
FDA Approves Weight Management Drug Amid Ozempic Lawsuits
MedTruth Editors · November 20, 2023
Zepbound, a drug for weight-related health conditions, helps regulate blood sugar by slowing the rate at which the stomach empties and suppressing appetite.
FDA RegulationAmid Hair Relaxer Lawsuits, FDA Considers Banning Formaldehyde
MedTruth Editors · October 25, 2023
Despite the well-documented health risks associated with formaldehyde, the chemical compound has not yet been banned by the FDA.
FDA RegulationFDA Warns Companies Selling Unapproved Eye Products
MedTruth Editors · October 20, 2023
Eight companies were warned for selling unapproved eye products, some of which contain silver, an ingredient that with long-term usage may cause the skin to turn blue.
FDA RegulationGet our reporting in your inbox
FDA Warns Infant Formula Manufacturers
MedTruth Editors · September 12, 2023
These inspections and recalls were intended to prevent distribution of formula contaminated with Cronobacter sakazakii.
FDA RegulationFDA Prepares For Implementation of MoCRA
MedTruth Editors · August 15, 2023
With the average American using between 6 and 12 cosmetic products every day, MoCRA was deemed a vital safety measure for consumer health.
FDA RegulationFDA Investigates Contaminated Abbott Laboratories Baby Formula
MedTruth Editors · March 30, 2023
The FDA and U.S. Attorney’s Office are investigating Abbott Laboratories for baby formula contamination.
FDA RegulationLate 2022 Reports Added to CPAP Device Communication
MedTruth Editors · March 14, 2023
Medical device reports received by the FDA at the end of 2022 have now been added to CPAP safety communication for public examination.
FDA RegulationFDA Announces Intent to Create CBD Pathway
MedTruth Editors · March 7, 2023
The FDA intends to balance the consumer’s desire for CBD products with its mandate to manage risk by implementing regulations on CBD.
FDA RegulationFDA Restricts Heavy Metal Levels for Baby Foods
MedTruth Editors · February 16, 2023
The recent FDA guidance aims to reduce heavy metal contamination in baby food while maintaining access to healthy foods.
FDA RegulationFDA Denies Marketing Permission to E-Cigarette Manufacturer
MedTruth Editors · February 14, 2023
The e-cigarette company is now forbidden from marketing or distributing their Vuse products in the U.S.
FDA RegulationFDA Issues Endoscope Warning Letters
MedTruth Editors · January 26, 2023
After a series of facility inspections, the leading manufacturer of endoscopes was found to have violated medical device reporting requirements and quality system regulations.
FDA RegulationFDA Announces Guidance for Unauthorized Homeopathic Treatments
MedTruth Editors · January 5, 2023
This guidance addresses unapproved homeopathic medicines as a response to the increase in these treatments being sold to the public.
FDA RegulationFDA Approves Type 1 Diabetes Prevention Medication
MedTruth Editors · December 8, 2022
The injectable Diabetes drug Tzield has been FDA-approved to delay the onset of stage 3 type 1 diabetes.
FDA RegulationFDA Warns About Dietary Supplement Cardiovascular Claims
MedTruth Editors · December 6, 2022
Supplement companies have illegally sold dietary supplements that claim to cure, treat, mitigate or prevent cardiovascular disease.
FDA RegulationFDA Explores Approving OTC Naloxone Products
MedTruth Editors · December 1, 2022
Narcan, a medication that prevents opioid overdose deaths, may be available over the counter in the future.
FDA RegulationFDA Warns Against Child-Friendly E-Cigarette Designs
MedTruth Editors · November 28, 2022
The e-cigarettes in question are shaped like electronics, TV show characters, and food items such as popsicles.
FDA RegulationFDA Issues Warning About Infant Head-Shaping Pillows
MedTruth Editors · November 22, 2022
The FDA recommends that parents and caregivers avoid using these pillows designed to change the shape of an infant’s head, and throw out any pillows that are already owned.
FDA RegulationFDA Recalls Mighty Bliss Heating Pads
MedTruth Editors · November 15, 2022
Mighty Bliss heating pads have been recalled for risk of shocks, burns and other injuries.
FDA RegulationFDA Rejects Menthol E-Cigarette Applications
MedTruth Editors · November 3, 2022
The FDA ruled that Logic's menthol e-cigarettes pose a public health risk and are not allowed on the market.
FDA RegulationFDA Develops Draft Guidance For Health Disparities
MedTruth Editors · November 1, 2022
The FDA is updating its Breakthrough Devices Program, providing clarifications that address health and healthcare disparities.
FDA RegulationNew Study Compells FDA Action Against E-Cigarette Manufacturers
MedTruth Editors · October 13, 2022
The FDA is cracking down on popular e-cigarette manufacturers found to be used by nearly 10% of middle and high school students according to a new study.
FDA RegulationFDA Proposes Updated Definition of "Healthy" Foods
MedTruth Editors · October 11, 2022
There is new suggested criteria for what kind of foods can be marketed as “healthy” based on types of ingredients and nutrient requirements.
FDA RegulationFDA Approves New Aid For Stroke Survivors
MedTruth Editors · September 29, 2022
A new device for stroke survivors with dysphagia has been certified safe to use and will be available for doctors to use in stroke treatment.
FDA RegulationMedtronic Recalls Obstructed Airway Tubes
MedTruth Editors · September 22, 2022
Endotracheal tubes are medical devices used during surgery to provide an airway for patients to breathe. A number of Medtronic models may become obstructed during use.
FDA RegulationFDA Recalls Additional Philips CPAP Devices
MedTruth Editors · September 15, 2022
Over 17 million CPAP machines have been recalled, this time due to defective magnets that can interfere with other implanted medical devices.
FDA RegulationFDA Approves Treatment For Rare Genetic Condition
MedTruth Editors · September 8, 2022
Acid Sphingomyelinase Deficiency is a debilitating condition that causes a lipid to build up in the liver, spleen, lungs and brain.
FDA RegulationFDA Approves OTC Hearing Aid Rules
MedTruth Editors · September 1, 2022
The ruling establishes a new category of hearing aids designed to be sold over the counter to adults with mild to moderate hearing impairment.
FDA RegulationFDA Cracks Down on Nicotine Gummies
MedTruth Editors · August 30, 2022
Krave Nic’s gummy products resemble candy and food products marketed to children, according to the FDA.
FDA RegulationFDA Strips Mammogram Clinic of Accreditation
MedTruth Editors · August 16, 2022
the FDA makes reports on mammogram facilities in order to allow providers and patients to make informed decisions about where they want to receive their mammogram.
FDA RegulationFDA Optimizes Remote Regulation Tools
MedTruth Editors · August 9, 2022
The initial benefits outlined by the agency included using RRAs to determine compliance, inform regulatory decisions, and verify information submitted to the agency.
FDA RegulationFDA Recalls At-Home Ventilators
MedTruth Editors · July 14, 2022
The FDA has issued a Class I recall of Baxter Healthcare Corporation’s Volara systems after severe side effects were discovered.
FDA RegulationFDA Warns of Baby Neck Float Dangers
MedTruth Editors · July 12, 2022
The FDA has warned parents and caregivers not to use neck floats for water therapy intervention.
FDA RegulationFDA Creates 5-Year Plan for Treating Neurodegenerative Diseases
MedTruth Editors · July 7, 2022
The FDA's plan aims to treat rare neurodegenerative diseases like Lou Gehrig's Disease or ALS through research, clinic trials, and more.
FDA RegulationFDA Proposes Plan For Limiting Nicotine in Cigarettes
MedTruth Editors · July 5, 2022
If implemented, the limit on nicotine would help to prevent people who experiment with cigarettes from becoming regular users.
FDA RegulationPhilips Respironics Ventilator Faces Second Recall
MedTruth Editors · June 14, 2022
The recall addresses the defect that causes these ventilators to completely shut down without prior warning.
FDA RegulationFDA Issues Supplement Guidance
MedTruth Editors · June 8, 2022
The FDA's new initiative aims to educate consumers about the risks and benefits of dietary supplements.
FDA RegulationFDA Approves New Diabetes Treatment
MedTruth Editors · June 7, 2022
The agency approved Mounjaro as a first of its class treatment to try to help meet diabetics' blood sugar goals.
FDA RegulationFDA Warns Companies Selling Illegal CBD Products
MedTruth Editors · June 2, 2022
In the warning letters, the FDA discusses the illegal marketing of these delta-8 THC products as treatments for medical conditions or for therapeutic use.
FDA RegulationFDA Releases Philips Recall FAQ
MedTruth Editors · May 30, 2022
The guide helps to determine if a Philips Respironics machine was recalled and what the risks are of using these recalled devices.
FDA RegulationFDA Warns of Counterfeit COVID-19 Tests
MedTruth Editors · May 26, 2022
The FDA stated that although no counterfeit COVID-19 tests have been found in government-distributed centers, the agency is aware they are being distributed around the US.
FDA RegulationFDA Approves Marketing of New Alzheimer's Test
MedTruth Editors · May 11, 2022
A new diagnostic test for Azlheimer's detection has been FDA-approved for marketing.
FDA RegulationFDA Proposes Flavored Tobacco Products Ban
MedTruth Editors · May 5, 2022
These bans have the potential to significantly decrease the rates of disease and death caused by burned tobacco products.
FDA RegulationFake Covid Drug Manufacturers Face FDA Action
MedTruth Editors · May 3, 2022
These latest actions are part of a continued effort to crack down on unapproved, untested, or ineffective treatments for Covid-19 being sold to consumers.
FDA RegulationFDA Proposes New Opioid Safety Initiative
MedTruth Editors · April 28, 2022
This new initiative would provide another avenue to traditional opioid disposal methods.
FDA RegulationFDA Issues Cybersecurity Guidance For Medical Devices
MedTruth Editors · April 21, 2022
Attacks from cybercriminals have rendered entire hospital networks powerless and have led to delays in diagnosis, delays in treatment, and increases in patient harm.
FDA RegulationFDA Rescinds Covid Drug Authorization
MedTruth Editors · April 14, 2022
Sotrovimab is an intravenous monoclonal antibody medication originally authorized for treating Covid-19.
FDA RegulationFDA Issues Warning to Unauthorized COVID Drug Makers
MedTruth Editors · April 12, 2022
Two companies that claim to make drugs that cure Covid-19 have been sent FDA warning letters.
FDA RegulationFDA Issues Rulings on E-Cigarette Products
MedTruth Editors · April 7, 2022
The FDA has been reviewing millions of E-cigarette products, approving ones that are likely to assist adult smokers looking to reduce or eliminate their combustible cigarette use.
FDA RegulationFDA Recalls Ventilators For Adhesive Defect
MedTruth Editors · March 29, 2022
Philips Respironics’ ventilators could stop functioning without warning or notification, potentially leading to patient deaths.
FDA RegulationFDA Approves First Generic Version of Symbicort
MedTruth Editors · March 24, 2022
Generic drugs help to improve accessibility of affordable medicine. Generic Symbicort will provide greater options for treatment to those with asthma and COPD.
FDA RegulationFDA Orders Phillips To Issue CPAP Warnings
MedTruth Editors · March 22, 2022
Some Philips CPAP and BiPAP machines use a foam that may break down and cause serious injury.
FDA RegulationFDA Approves New Heart Disease Treatment
MedTruth Editors · March 3, 2022
This new heart medication adds another treatment option to reduce the risk of cardiovascular death and hospitalization due to heart failure.
FDA RegulationFDA Recalls Fraudulent Covid Tests
MedTruth Editors · February 25, 2022
Two Covid tests labeled as FDA-approved have been recalled. The FDA recommends retesting with an authorized test and reporting any false results.
FDA RegulationFDA Requests Public Comment on Credibility of Medical Device Models
MedTruth Editors · February 17, 2022
The new guidance will be used to support medical devices in the submission processes for a number of FDA approvals and clearances.
FDA RegulationFDA Releases Patient Feedback Guidance
MedTruth Editors · February 3, 2022
The goal of these new guidances is to give patients and advocates a voice in the medical device process.
FDA RegulationFDA-Approved COVID Testing Roundup
MedTruth Editors · January 20, 2022
The FDA has updated the Emergency Use Authorization clearance status of various different types of COVID-19 diagnostic tests.
FDA RegulationFDA Recalls Medtronic Ventilators After Complaints and Death
MedTruth Editors · January 13, 2022
The ventilators have an error that can cause the devices to stop working as intended and become inoperable, which can lead to neurological injury and, if left unchecked, death.
FDA RegulationFDA Warns Medtronic Over Faulty Insulin Pumps
MedTruth Editors · January 11, 2022
In an inspection of Medtronic’s firm, the FDA found four major failures in the facility’s insulin pump manufacturing practices.
FDA RegulationFDA Greenlights the First E-Cigarette Products for Sale
MedTruth Editors · November 5, 2021
The FDA has has authorized the first e-cigarette on the market, and it's not JUUL.
FDA RegulationThe 510(k) Approval Process: A Guide
MedTruth Editors · October 19, 2021
Manufacturers can use the 510(k) process as long as their new medical device is appropriately similar to a device that has already been approved.
FDA RegulationVaccine Adverse Event Reporting System: A Guide
MedTruth Editors · October 7, 2021
By understanding the benefits and limitations of VAERS, consumers can advocate for their health in a more informed way.
FDA RegulationFlorida Compounding Pharmacy Punished by Federal Court
MedTruth Editors · September 28, 2021
The U.S. federal court has placed a permanent injunction prohibiting a Florida-based pharmaceutical company from producing or distributing any drugs.
FDA RegulationFDA Spares JUUL From Market Dismissal
MedTruth Editors · September 21, 2021
The FDA's judgment on JUUL is in the final stages of review.
FDA RegulationFDA Public Workshop To Standardize Opioid Education
MedTruth Editors · September 15, 2021
The FDA will conduct a workshop to review the education that opioid prescribers receive in an attempt to reduce the recreational use of opioids.
FDA RegulationNew Guide Teaches Consumers How to Verify FDA Approved Medical Products
MedTruth Editors · March 18, 2021
Following an increase in fake “FDA Registration Certificates,” the FDA published an online consumer guide to medical device approval.
FDA RegulationFDA Acts to Protect Consumers from Fake "FDA Certified" Health Care Products
James Parker · March 9, 2021
The FDA sent letters to 25 printing firms to stop producing fake “FDA registration certificates.”
FDA RegulationOfficials Seize 42 Shipments of Fake Vapes from China
Kristen Fischer · January 20, 2021
Government officials seized 42 shipments of counterfeit e-cigarettes, including Puff Bar knockoffs.
FDA RegulationFibroid Removal Safety Recommendations Updated by FDA
Carah Wertheimer · January 7, 2021
The FDA has finalized safety recommendations for the use of power morcellators in surgeries to remove fibroids.
FDA RegulationSenators Demand Answers From FDA on Imported Drug Safety
MedTruth Editors · November 24, 2020
Senators Elizabeth Warren and Tina Smith have voiced concerns around reductions in FDA oversight of foreign drug manufacturing facilities.
FDA RegulationNSAIDs Can Increase Risk of Pregnancy Complications, FDA Warns
Nicole Knight · October 28, 2020
A new warning for pregnant people will appear on prescription and over-the-counter NSAIDs.
FDA RegulationFDA Warns Against Dental Amalgams for Groups Sensitive to Mercury
James Parker · October 26, 2020
Certain individuals are instructed to avoid getting “silver” fillings due to mercury exposure concerns.
FDA RegulationMore Recalls Issued for Diabetes Drug Metformin
Nicole Knight · October 15, 2020
The FDA has announced two additional voluntary recalls of extended-release metformin.
FDA RegulationFDA Issues Guidance on Drug Impurities
MedTruth Editors · September 8, 2020
The FDA announced new guidance on Sept. 1 for drugmakers, citing “serious concerns” about common medications.
FDA RegulationQuestions Remain About COVID-19 Vaccine Review
T.J. La · August 31, 2020
Operation Warp Speed aims to deliver 300 million doses of a safe, effective vaccine for COVID-19 by January 2021, but there's growing concern about lack of FDA review.
FDA RegulationFDA No Longer Regulating Many COVID-19 Tests
T.J. La · August 27, 2020
Although affected labs are no longer required to seek FDA clearance, approval or emergency use authorizations for their tests, they may voluntarily continue to do so.
FDA RegulationExpanding FDA List of Potentially Toxic Hand Sanitizers Hits 77
MedTruth Editors · July 24, 2020
The list of hand sanitizers potentially contaminated with toxic methanol has continued to grow since the FDA first raised concerns in June.
FDA RegulationAdditional Metformin Lots Voluntarily Recalled Due to Contamination Concerns
James Parker · July 16, 2020
The FDA issued a pair of new recall alerts for select extended-release batches of metformin, a popular drug used to control type 2 diabetes.
FDA RegulationAdverse Event Reporting Resumes After COVID Hiatus
James Parker · June 24, 2020
The slowdown in adverse event reporting can be attributed to an official regulatory pause for a period of two months.
FDA Regulation43 Homeopathic Drugs Included in Recent FDA Warning Letters
Lauren Styx · June 17, 2020
The FDA has issued warning letters to four manufacturers for selling unapproved homeopathic drug products. The warning letters target homeopathic products such as Arnica.
FDA RegulationFDA Names More Companies Recalling Metformin for NDMA Contamination
Emily Rose Thorne · June 15, 2020
Since the FDA found NDMA above the acceptable intake limit in certain lots of metformin, five pharmaceutical companies have announced a voluntary recall of extended-release (ER) metformin, a popular medication used to control type 2 diabetes.
FDA RegulationFDA Singulair Warning Cautions Patients of Psychiatric Risks
James Parker · June 9, 2020
The FDA Singulair warning addressed a troubling connection between the medication and an increased risk of neuropsychiatric events, including agitation and depression.
FDA RegulationFDA Issues Warning Letters to Hold Breast Implant Manufacturers Accountable
Lauren Styx · June 4, 2020
As part of its ongoing efforts to protect patients, the FDA issued warning letters to two breast implant manufacturers citing violations of quality system and medical device reporting regulations.
FDA RegulationCanadian Drug Co. Apotex Recalls Metformin Due to NDMA Contamination
MedTruth Editors · May 29, 2020
Metformin was voluntarily recalled after N-Nitrosodimethylamine (NDMA) was discovered in a single lot of Apotex’s product.
FDA RegulationCME Pump Recall Initiated For Inaccurate Medication Dispensing
James Parker · April 13, 2020
CME America’s BodyGuard Infusion Pump Systems have been recalled due to potentially fatal defects in medication dispersal.
FDA RegulationFDA Pipeline Recall Initiated to Protect Aneurysm Patients
James Parker · April 9, 2020
The FDA has recalled Medtronic's Pipeline Flex Embolization products after the organization discovered that the device could fracture during or after placement.
FDA RegulationFDA Warns Patients to Stop Taking SGLT-2 Inhibitors Before Surgery
James Parker · April 3, 2020
The FDA released a warning about continuing the use of sodium-glucose co-transporter-2 inhibitors before surgery, informing patients that the class of diabetes medications could contribute to a higher risk of ketoacidosis.
FDA RegulationFDA Finds Asbestos in Cosmetics, Consumer Protection Bill Introduced
James Parker · March 25, 2020
The FDA's year-long probe into potential asbestos contamination in talc-containing cosmetic products and baby powder is over, and the results are in: contamination was found in 9 out of 52 samples.
FDA RegulationHundreds of Thousands of Medtronic Insulin Pumps Recalled
Kimberly Nicoletti · March 6, 2020
Medtronic has recalled about 322,000 defective insulin pumps used by type 1 diabetics. The pumps from the MiniMed 600 series can deliver too much or too little insulin due to missing or broken retainer rings.
FDA RegulationFDA Bans Electrical Stimulation Devices After Identifying Substantial Risk
James Parker · March 5, 2020
The FDA has banned electrical stimulation devices, used for self-injurious or aggressive behavior, due to significant psychological and physical risks.
FDA RegulationWeight Loss Drug Belviq Withdrawn Over Cancer Concerns
S. Nicole Lane · February 24, 2020
The FDA requested a manufacturer recall of the weight-loss drug Belviq (lorcaserin hydrochloride) after studies showed an increased risk of cancer.
FDA RegulationFDA's New Policy Loosens Medical Device Approval Process
Nicole Knight · February 18, 2020
The FDA has exempted more than 200 types of medical devices and testing products from safety and effectiveness reviews after a new policy went into effect Dec. 30.
FDA RegulationFDA Updates Recognized Consensus Standards for Medical Devices
Benjamin Duong · January 28, 2020
The FDA published more than 80 additions, withdrawals or modifications to its list of recognized consensus standards for medical devices in the U.S. market, impacting devices such as cardiovascular stents and nails used to secure implants to bones.
FDA RegulationEthicon Stapler Recall Removes Over 90,000 Units From Circulation
James Parker · January 27, 2020
The FDA is enforcing an Ethicon stapler recall after units were ejecting malformed staples.
FDA RegulationFDA Final Rule Requires Medical Device Submissions in Electronic Format
Nicole Knight · January 21, 2020
As of Jan. 15, 2020, the FDA requires electronic submission of medical device premarket applications in efforts to increase approval transparency and cut down on paperwork.
FDA RegulationFDA Gabapentinoid Warning Focuses on Respiratory Complications
James Parker · January 21, 2020
The FDA issued a warning about respiratory depression and serious breathing difficulties in patients using gabapentin. Certain factors, including pre-existing respiratory complications and opioid use, may increase the risk.
FDA RegulationFDA Schedules Public Meeting to Assess Testing for Asbestos in Talc
James Parker · January 13, 2020
The public meeting may be crucial to qualifying expert witnesses for thousands of plaintiffs involved in national talcum powder cases.
FDA RegulationMore Companies Pull Heartburn Meds to Participate in FDA Ranitidine Recall
James Parker · January 13, 2020
Appco Pharma and Denton Pharma have voluntarily recalled generic versions of Zantac (ranitidine) to align with the FDA's efforts to remove drugs from circulation that may contain more than 96 nanograms of NDMA per million nanograms of ranitidine.
FDA RegulationFDA Metformin Probe Investigates Potential NDMA Hazard
James Parker · January 8, 2020
An investigation will determine whether the diabetes drug metformin contains dangerously elevated levels of the carcinogen NDMA, as part of a larger movement to examine a wide spectrum of medications for unsafe levels of contamination.
FDA RegulationEthylene Oxide and Concerns With Medical Device Sterilization
Nicole Knight · January 6, 2020
Ethylene oxide, a gas used to sterilize more than half of medical devices in the U.S., can cause cancer. As agencies begin to regulate the gas, hospitals may face potential medical device shortages due to the lack of an acceptable sterilization alternative.
FDA RegulationFDA Approves First Single-Use, Disposable Duodenoscope
James Parker · January 6, 2020
The Exalt Model D, manufactured by Boston Scientific, is the first single-use duodenoscope approved for physicians.
FDA RegulationHealth Canada Introduces Medical Devices Directorate
Benjamin Duong · December 10, 2019
The MDD will allow Health Canada to better regulate medical device technology during its entire lifecycle — from research and development to use by patients and providers.
FDA RegulationFDA Panel Reveals: Not All Medical Devices Created Equal
Crystal Duan · December 6, 2019
The FDA hosted a public advisory committee meeting to discuss the adverse health impacts of metals in medical devices, such as dental amalgam, Paragard contraceptives and hip implants.
FDA RegulationFDA Warns CBD Companies For Violating Federal Law
James Parker · December 4, 2019
The FDA sent warning letters to 15 companies regarding the illegal sale of CBD products.
FDA RegulationFDA Updates Watch List With Xofluza and Other Drugs
Benjamin Duong · November 21, 2019
The FDA recently updated its watch list, adding more than a dozen medications, including drugs that may cause anaphylaxis, angioedema, miscarriage, hypersensitivity reactions and other side effects.
FDA RegulationFDA Encourages Use of Disposable Duodenoscopes
Tess Francke · November 18, 2019
Traditional duodenoscopes may cause infection. The FDA recommends hospitals transition to disposable duodenoscopes and warns against illegal ATP test strips used to determine cleanliness.
FDA RegulationFDA May Withdraw Premature Birth Prevention Drug From Market
Carah Wertheimer · November 8, 2019
Premature birth prevention drug Makena may be withdrawn due to an FDA advisory panel vote.
FDA RegulationFDA Wants Recall of Zantac and Axid Amid Cancer Concern
Carah Wertheimer · November 5, 2019
Zantac, a commonly used heartburn medication, can contain the carcinogenic toxin NDMA, prompting the FDA to issue a voluntary recall.
FDA RegulationFDA Wants Recall of Zantac and Axid Amid Cancer Concern
Carah Wertheimer · November 5, 2019
Zantac, a commonly used heartburn medication, can contain the carcinogenic toxin NDMA, prompting the FDA to issue a voluntary recall.
FDA RegulationFDA Warns of Lung Inflammation Caused by Breast Cancer Drugs
Tess Francke · October 31, 2019
The FDA warns patients of lung inflammation caused by breast cancer medications Ibrance, Kisqali and Verzenio.
FDA RegulationFDA Recommends Black Box Warnings on Breast Implants
Carah Wertheimer · October 24, 2019
The FDA has just released a 21-page document articulating the risks and benefits associated with breast implants to ensure that all consumers have access to "complete information" on the medical devices. This is the agency’s first update to breast implant consumer information practices since 2006. All members of the public and professionals of the medical world are invited to comment within the next 60 days for any revisions to the draft before the document is finalized.
FDA RegulationStudies, Regulatory Updates on Flavored E-Cigarettes
Nicole Knight · October 24, 2019
A surge in teen vaping is causing lawmakers to push the FDA to ban flavored e-cigarettes. Teens who use flavored e-cigs are more likely to start using tobacco, according to recent research.
FDA RegulationFDA Receives Thousands of Public Comments on Glyphosate, Re-Approval Pending
Carah Wertheimer · September 10, 2019
The Food and Drug Administration received 114,855 public comments regarding the safety of Monsanto’s herbicide Roundup, which is currently under review for renewed registration.
FDA RegulationFDA Alert Indicates Some Medtronic Pacemaker Batteries Can Fail Without Warning
Benjamin Duong · August 21, 2019
The U.S. Food and Drug Administration (FDA) issued a safety alert in May regarding the batteries of implantable pacemakers and cardiac resynchronization therapy pacemakers (CRT-P) from the medical device company, Medtronic.
FDA RegulationFDA Will Add Graphic Warning Labels to Cigarette Packages
James Parker · August 15, 2019
On Aug. 15, the U.S. Food and Drug Administration released a new rule requiring warning labels on cigarette boxes. Full-color cigarette warnings must be included on all cartons with images of side effects, including blindness, amputation and bladder cancer.
FDA RegulationFirst New Mesothelioma Treatment in 15 Years Approved by FDA
James Parker · August 8, 2019
Manufactured by Novocure, the FDA-approved mesothelioma treatment, NovoTTF-100L is the newest option for MPM since Pemetrexed. NovoTTF-100L was approved under the FDA Humanitarian Device Exemption, which is an expedited regulatory pathway intended to approve treatments for rare diseases.
FDA RegulationFDA Stops Sales of Transvaginal Mesh
Carah Wertheimer · April 19, 2019
The FDA gave transvaginal mesh companies Boston Scientific and Coloplast 10 days to submit plans to withdraw their products from the market - officially ending transvaginal mesh sales. Unfortunately for many, the damage has been done.
FDA RegulationFDA Announces Intent to Look Into Potential “Vape Seizures”
James Parker · April 4, 2019
The U.S. Food and Drug Administration (FDA) announced today that they would begin looking into a potential link in a series of vape seizures that seem to be affecting young adults. The FDA became aware of the issue when conducting reviews of adverse event reporting related to vape use as part of their initiative to fully define the direct and indirect risks associated with the product.
FDA RegulationFDA Public Advisory Committee Addresses Breast Implant Safety
Lauren Delisle · March 28, 2019
On March 25th, the U.S. Food and Drug Administration (FDA) began a two-day Public Advisory Committee meeting to discuss the safety of breast implants and their potential links to life-threatening health problems.
FDA RegulationInside the Opioid Crisis: Pet Prescriptions & Vets
Carah Wertheimer · March 25, 2019
Pet owners desperate to get opioids are intentionally harming their animals. Recent studies surrounding the opioid crisis reveal an increase in the abuse and misuse of veterinary opioid prescriptions.
FDA RegulationFDA Issues Letter on Increasing Danger of Surgical Staples
Carah Wertheimer · March 21, 2019
There have been more than 9,000 serious injuries and 32,000 malfunctions related to surgical staples. On March 8, the FDA issued a letter to healthcare providers expressing concern for the issue and recommending safety measures for safety.
FDA RegulationSGLT2 Amputation: Can Medication Contribute to Diabetes Amputations?
Benjamin Duong · February 12, 2019
A popular class of diabetes medications in 2019 may cause an increased risk of amputation, in addition to other complications such as diabetic ketoacidosis, acute kidney injury and serious urinary tract infection, SGLT2 amputation creates another risk for patients with diabetes.
FDA RegulationFDA Attempts to Update Medical Device Regulation
Carah Wertheimer · February 11, 2019
The Food and Drug Administration (FDA) is updating its medical device regulation process to better align with the rapid pace of technological advancement.
FDA RegulationFDA Dismissed Citizen Petition for Plavix Labeling
James Parker · January 18, 2019
The FDA recently dismissed a petition to add a new black-box label to the popular blood thinner Plavix.
FDA RegulationFDA Warns of Stroke and Complications with Lemtrada for MS
Tess Francke · December 6, 2018
The FDA is warning Lemtrada consumers about cases of stroke and blood vessel wall tears in the lining of arteries in the head and neck, called arterial dissection, that lead to permanent disability or death.
FDA RegulationBenzocaine and Babies: FDA Warns Teething Gels May Be Life-Threatening
Carah Wertheimer · November 30, 2018
A recent FDA warning alerts families that baby teething gels with benzocaine may cause a rare but serious blood disorder.
FDA RegulationFDA Warns of E-Cig Burns, Erectile Dysfunction Drugs in Vape Juice
James Parker · November 16, 2018
As the FDA struggles to regulate e-cigarette marker, the agency has warned against e-cig burns, device explosions and even liquids containing erectile dysfunction drugs.
FDA RegulationFDA Approves First New Flu Treatment in Nearly 20 Years
Tess Francke · November 6, 2018
A single-dose flu pill, Xofluza, is the only new flu treatment approved by the FDA in nearly 20 years. The medication could cost between
FDA RegulationEstrogel Maker Ascend Therapeutics Under FDA Fire Yet Again
Carah Wertheimer · October 29, 2018
The FDA reprimanded Ascend Theraputics for misleading consumers about the lowest effective dose of Estrogel. Higher doses may increase the risk of Estrogel side effects, such as uterine cancer.
FDA Regulation3 Common U.S. Drugs Outlawed in Europe
Nicole Knight · October 24, 2018
The European Medicines Agency strictly regulates medications and consumer products. Americans taking popular drugs, such as Avandia, may not realize there are major differences between FDA and EMA approval.
FDA RegulationCanadian Warning for Chemo Drug Tasigna Differs from U.S. Label
Tess Francke · September 19, 2018
In 2013, Health Canada warned its citizens about a potentially deadly cardiovascular side effect linked to a chemotherapy drug.
FDA RegulationFDA Warns of Rare Genital Gangrene Linked to SGLT2 Diabetes Drugs
James Parker · September 17, 2018
People with diabetes taking Invokana and other SGLT2 inhibitors may be at risk for Fournier's gangrene, a flesh-eating bacterial infection affecting the groin and genitals. SGLT2 inhibitors that may potentially cause Fournier's gangrene include Invokana, Farxiga and Jardiance.
FDA RegulationFDA Takes A Stand Against The Flood of Underage Juul Users
James Parker · September 12, 2018
As the use of Juul vaporizers and other e-cigarettes among teens rises, the FDA reviews the company's youth marketing efforts and fines retailers for selling to minors.
FDA RegulationFDA is "Deeply Concerned" About Vaginal Rejuvenation Risks
Ashley Lombardo · August 7, 2018
Medical device manufacturers are deceptively marketing energy-based therapies for vaginal rejuvenation—an unapproved, risky procedure that may harm women.
FDA RegulationFDA Reveals Pharma Companies Blocking Cheaper Generic Medications
Ashley Lombardo · June 27, 2018
In an effort to lower drug prices, the FDA released a list of companies refusing to provide samples of life-saving drugs. Samples are necessary to develop less expensive generic versions.
FDA RegulationPhilippine FDA Warns of Talc in Cosmetics
James Parker · April 30, 2018
The Philippine FDA recently issued a consumer advisory about potential asbestos contamination in cosmetic talcum powder.
FDA RegulationIs Kratom an Opioid? FDA Says Yes
Ashley Lombardo · February 16, 2018
The Food and Drug Administration released a public health advisory about risks associated with kratom, labeling the drug an opioid and blocking imports from Asia.
FDA RegulationFDA Issues St. Jude Medical Defibrillator Recall
Ashley Lombardo · February 6, 2018
The FDA issued an updated safety warning for certain defibrillation devices with faulty batteries. The defibrillator recall attempts to protect patients from a stopped heart.
FDA RegulationManufacturers Submit Application For New Xarelto Uses
Ashley Lombardo · February 3, 2018
Despite no antidote for its severe side effects, Janssen Pharmaceuticals, parented by Johnson & Johnson, has submitted an FDA application for two new Xarelto uses.
FDA RegulationFDA Delays AndexXa Antidote for Xarelto Bleeding
Ashley Lombardo · January 24, 2018
The AndexXa antidote, intended to stop Xarelto bleeding, awaits FDA approval. The agency will revisit the data in May 2018.
FDA RegulationMorcellator Use Declines Following FDA Warning
Ashley Lombardo · January 17, 2018
The FDA has affirmed a four-year-old warning over the risk of developing uterine sarcoma after undergoing surgery with morcellation.
FDA RegulationBefore Having an MRI, Know More About GBCAs
Ashley Lombardo · January 4, 2018
The FDA has updated its safety warning about GBCAs. Learn more about the effects of gadolinium, the rare earth metal that can build up in your system after an MRI.
FDA RegulationXarelto Gets FDA Approval to Extend VTE Prevention
Ashley Lombardo · November 17, 2017
The Food and Drug Administration approved the blood thinner Xarelto for extended VTE prevention. The medication has been linked to severe bleeding.
FDA RegulationreSET Sobriety App Approved By FDA
Ashley Lombardo · September 22, 2017
The reSET sobriety app, approved by the FDA, combines an incentivized addiction treatment program with cognitive behavioral therapy.
FDA RegulationFDA Approves New Drug to Treat Follicular Lymphoma
Ashley Lombardo · September 19, 2017
The FDA has approved a new drug to treat follicular lymphoma, a type of non-Hodgkin's lymphoma that typically affects patients over 60.
FDA RegulationFDA Updates Consumers on How to File Adverse Event Reports
Ashley Lombardo · March 13, 2017
The Food and Drug Administration issued a consumer update to provide information about how to file adverse event reports.
FDA RegulationFDA Releases Update on Public Participation in Clinical Trials
Ashley Lombardo · January 20, 2017
The Food and Drug Administrations (FDA) seeks more diverse participants in FDA clinical trials, according to a January consumer update.
FDA RegulationAdverse Event Data On Food, Supplements And Cosmetics Goes Public
Ashley Lombardo · January 4, 2017
the Food and Drug Administration (FDA) will publish adverse event data on products outside the drugs and medical device category.
FDA RegulationTestosterone Label Updated to Illustrate Dependency Risk
Ashley Lombardo · December 16, 2016
The Food and Drug Administration updated labeling to reflect a dependency risk linked to testosterone abuse.
FDA RegulationThe Controversial 21st Century Cures Act
Ashley Lombardo · December 8, 2016
The 21st Century Cures Act would expand research funding and update the FDA approval process. it could also limit off-label prescriptions.
FDA RegulationFDA Releases Guidelines for Bipolar Disorder and Depression
Ashley Lombardo · December 2, 2016
Bipolar disorder and depression are unique conditions, prompting the FDA to release guidelines to better understand bipolar treatments and depression medications.
FDA RegulationFDA Updates Vaginal Mesh Warning and Risk Classification
Ashley Lombardo · October 7, 2016
The Food and Drug Administration released a vaginal mesh warning, updating the public on mesh side effects.
FDA RegulationFDA Recommends Questions to Ask Before Mesh Surgery
Ashley Lombardo · September 28, 2016
The Food and Drug Administration released a set of questions to ask before mesh surgery to reduce the number of vaginal mesh side effects, the
FDA RegulationLawmakers Propose Amendments to Cosmetics Act
Ashley Lombardo · August 24, 2016
After Wen Hair Care products left consumers with a balding side effect, advocates have pushed to reform the regulatory cosmetic act.
FDA RegulationFDA Strengthens Kidney Warnings On Diabetes Drugs
Ashley Lombardo · July 24, 2016
The Food and Drug Administration (FDA) has updated warnings on four diabetes medications to minimize the risk of acute kidney injury. Used to treat type II diabetes, canagliflozin and dapagliflozin are sodium-glucose cotransporter-2 (SGLT2) inhibitors that work with the kidneys to maintain safe blood sugar levels.
FDA RegulationWhat Is the 510(k) Clearance Program?
Ashley Lombardo · July 10, 2016
The 510(k) clearance program is an FDA approval process that fast-tracks new drugs to market.
FDA RegulationPublic Citizen Petitions FDA to Take Action on Invokana Ads
Ashley Lombardo · June 24, 2016
On March 31, 2015, Public Citizen issued a petition to encourage the FDA to take action and regulate misleading Invokana ads.
FDA RegulationWhat Is a Black Box Warning?
Ashley Lombardo · May 2, 2016
The Food and Drug Administration adds a black box warning to pharmaceutical product labeling to inform the public of health and safety risks.
FDA Regulation