FDA Regulation

An illustration of two scientists checking the data on a blackboard, representing MedTruth's FDA regulation coverage area.

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

A photo of an FDA-recommended disposable duodenoscope, prior to recommendations to use disposable duodenoscopes.

FDA Encourages Use of Disposable Duodeno...

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
A close-up photo of a dark-skinned man with hazel eyes, representing the current focus on LASIK risk and safety.

Former FDA Adviser Draws Attention to Co...

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.

A photo of an elderly woman clutching her chest from heartburn before taking Zantac (ranitidine), which may cause NDMA carcinogenic toxins.

FDA Wants Recall of Zantac and Axid Amid...

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
Image of a doctor holding a breast implant representing the 510(k) approval process by the FDA.

The 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 Regulation
Image of a medical professional with a vaccine syringe representing VAERS.

Vaccine 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 Regulation
Image of pharmaceutical manufacturing machine representing the Florida compounding pharmacy shut down by the FDA.

Florida 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 Regulation
Image of a teen vaping representing the FDA sparing JUUL from market dismissal.

FDA Spares JUUL From Market Dismissal

MedTruth Editors · September 21, 2021

The FDA's judgment on JUUL is in the final stages of review.

FDA Regulation
Image of a doctor writing opioid prescriptions.

FDA 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 Regulation
Image of a doctor and an FDA official representing the FDA medical device approval process.

New 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 Regulation
Image of a person signing FDA documents representing fraudulent medical device registration claims.

FDA 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 Regulation
Picture of a person holding a JUUL E-cigarette.

Officials 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 Regulation
Image of a woman holding her stomach, representing fibroid surgery safety recommendations by the FDA.

Fibroid 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 Regulation
Image of an FDA employee inspecting foreign drugs.

Senators 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 Regulation
Image of a pregnant people worried about NSAIDs increasing risk of pregnancy complications.

NSAIDs 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 Regulation

FDA 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 Regulation
Image of white pills representing the Metformin recall.

More Recalls Issued for Diabetes Drug Metformin

Nicole Knight · October 15, 2020

The FDA has announced two additional voluntary recalls of extended-release metformin.

FDA Regulation
Image of a hand holding a white pill under FDA guidance on drug impurities.

FDA 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 Regulation
Image of a doctor administering a coronavirus vaccine for Operation Warp Speed.

Questions 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 Regulation
Image of a healthcare official holding a coronavirus testing kit that is no longer regulated by the FDA.

FDA 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 Regulation
Image of a woman using hand sanitizer, representing the FDA recall.

Expanding 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 Regulation
Image of Metformin pills that were voluntarily recalled.

Additional 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 Regulation
Person on laptop during FDA reporting hiatus.

Adverse 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 Regulation
Image of homeopathic drugs that were included in recent FDA warning letters.

43 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 Regulation
Woman with diabetes thinking about the metformin recall due to NDMA contamination.

FDA 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 Regulation

FDA 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 Regulation
Image of breast implants representing the FDA warning letters to breast implant manufacturers.

FDA 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 Regulation
Image of Metformin pills representing the metformin recall.

Canadian 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 Regulation
Man attached to infusion therapy machine representing the CME Pump Recall.

CME 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 Regulation
Image of a brain scan of an aneurysm patient, representing the FDA Pipeline embolization recall.

FDA 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 Regulation
A photo of a diabetes patient learning about the risks of taking type 2 diabetes medications before surgery.

FDA 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 Regulation
Image of eyeshadow on woman's fingers, representing the FDA finding asbestos in cosmetics.

FDA 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 Regulation
Person with a Medtronic MiniMed 600 series insulin pump which was recalled by the FDA.

Hundreds 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 Regulation
Illustration of a head representing mental illness and the Electrical Stimulation Devices ban.

FDA 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 Regulation
Belviq weight loss drug pills spilled out of the bottle after it was withdrawn over cancer concerns.

Weight 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 Regulation
FDA signing medical device approvals.

FDA'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 Regulation
A photo of a person typing in reference to the FDA's recognized consensus standards for medical devices.

FDA 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 Regulation
Doctor using a recalled Ethicon surgical stapler.

Ethicon 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 Regulation
A photo of a doctor using a stethoscope to listen to the breathing of an elderly man who developed respiratory complications from gabapentin.

FDA 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 Regulation
Photo of doctor's hands on laptop keyboard submitting electronic approval of medial device after mandated by the FDA

FDA 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 Regulation
A photo of an Asian pharmacist removing medications from the pharmacy shelf, representing the recent news around the FDA Ranitidine recall.

More 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 Regulation
A photo of a woman sitting and facing a public meeting, representing the pending FDA asbestos identification meeting on asbestos in talc.

FDA 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 Regulation
A photo of white pills, representing the FDA's metformin probe to assess if it contains unsafe levels of NDMA.

FDA 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 Regulation
A photo of sterilized vaginal speculum, a medical device that may be sterilized with ethylene oxide.

Ethylene 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 Regulation
A photo of a medical assistant holding a duodenoscope, representing the recent FDA approval for a disposable, single use endoscopy device.

FDA 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 Regulation
A photo of a Canadian flag, representing Health Canada's Medical Device Directorate.

Health 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 Regulation
Photo of knee and hip implants which were discussed at an FDA Panel addressing metal-containing medical devices and dental amalgam implants.

FDA 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 Regulation
Cannabis tincture representing the FDA CBD warning letters

FDA 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 Regulation
A photo of a woman's hand holding medication, representing the FDA's recent addition to the drug watch list.

FDA 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 Regulation
A photo of an FDA-recommended disposable duodenoscope, prior to recommendations to use disposable duodenoscopes.

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
Pregnant woman thinking about premature birth prevention drug Makena

FDA 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 Regulation
A photo of an elderly woman clutching her chest from heartburn before taking Zantac (ranitidine), which may cause NDMA carcinogenic toxins.

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
A photo of a nurse checking a breast cancer patient's lung inflammation in relation to Ibrance, Kisqali and Verzenio.

FDA 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 Regulation
Teen vaping a flavored e-cigarette

Studies, 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 Regulation
A photo of a woman on her computer perusing FDA website after issuing Black Box Warnings on Breast Implants. 

FDA 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 Regulation
Person on computer reads about FDA potential re-approval of glyphosate

FDA 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 Regulation

FDA 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 Regulation
A photo of vintage cigarette boxes to represent the new FDA Cigarette Warning Label plan.

FDA 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 Regulation
Illustration of MRI scan of lungs for mesothelioma as the FDA approves the first mesothelioma treatment in 15 years.

First 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 Regulation
A photo of a woman with transvaginal mesh after news of Transvaginal Mesh Sales Halted by FDA.

FDA 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 Regulation
Illustration of fist holding e-cigarette after vaping linked to seizures.

FDA 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 Regulation
Woman at Breast Implant FDA Meeting

FDA 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 Regulation
Dog and cat impacted by the opioid crisis

Inside 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 Regulation
A woman suffering with surgical staples pain

FDA 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 Regulation
A man wondering about the risk of SGLT2 amputation in diabetics.

SGLT2 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 Regulation
Doctor holding medical device representing FDA medical device regulation

FDA 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 Regulation
A photo of pills on Plavix regarding the FDA update

FDA 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 Regulation
A photo of a woman in a wheelchair and her caregiver looking out the window wondering about stroke and death associated with Lemtrada for MS.

FDA 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 Regulation
A photo of a teething baby after FDA teething gels warning for babies is released.

Benzocaine 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 Regulation
Photo of Vape Juice bottles after FDA warns of relationship between vape juice and erectile dysfunction.

FDA 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 Regulation
Photo of girl blowing her nose as FDA approves first news Flu Treatment in Nearly 20 Years.

FDA 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 Regulation
Photo of Estrogel on a woman's hand despite FDA criticism about the female estrogen product.

Estrogel 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 Regulation
Photo of hand holding globe to demonstrate global differences on drug approvals with FDA allowing drugs Outlawed in Europe.

3 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 Regulation
A photo of a beautiful and bald black woman after undergoing chemo with chemo drug Tasigna.

Canadian 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 Regulation
A photo depicting a doctor talking with diabetes patient after FDA warns of rare genital gangrene linked to SGLT2 Diabetes Drugs.

FDA 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 Regulation
Photo of man exhaling smoke from e-cigarette after FDA makes JUUL Public Health Warning for use by minors.

FDA 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 Regulation
Grapefruit representing FDA announcement of vaginal rejuvenation treatment

FDA 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 Regulation
fda generic vs brand name drugs

FDA 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 Regulation
Talc in Cosmetics

Philippine 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 Regulation
Is Kratom an Opioid, Mitragyna speciosa leaves

Is 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 Regulation
Man holding chest, representing St. Jude Medical Defibrillator Recall

FDA 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 Regulation
Pile of Xarelto pills for new Xarelto sses

Manufacturers 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 Regulation
A photo of a man in a lab, working on creating the AndexXa antidote for Xarelto bleeding.

FDA 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 Regulation
A photo of a woman in a doctor's office, refusing power morcellator treatment for uterine fibrioids after the FDA warning.

Morcellator 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 Regulation
A photo of an elderly man getting an MRI with a nurse leaning over her patient, explaining what he needs to know about GBCAs before his MRI.

Before 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 Regulation
A photo of Xarelto pills in a clear disk, representing Xarelto becoming approved for VTE prevention.

Xarelto 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 Regulation
A photo of a person holding a phone, representing the reSET sobriety app.

reSET 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 Regulation
A photo of a female physician examining a male patient's lymph nodes, checking for follicular lymphoma.

FDA 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 Regulation
A photo of a woman's hand using a mouse near a keyboard, reporting adverse events to the FDA.

FDA 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 Regulation
A photo of a group of diverse women and men participating in clinical trials.

FDA 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 Regulation
Pink table with laptop, cup of coffee, donut, bracelets, lipstick, and nail polish.

Adverse 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 Regulation
An illustration of the FDA labeling update to indicate testosterone therapy risks.

Testosterone 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 Regulation
An illustration of scientists researching under the expanded funding of the 21st Century Cures Act.

The 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 Regulation
An illustration of a young woman with depression learning about the FDA guidelines for antidepressants and antipsychotic medication.

FDA 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 Regulation
An illustration of the Food and Drug Administration's safety communication on vaginal mesh warnings.

FDA 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 Regulation
An illustration of questions to ask before mesh surgery checklist on a clipboard.

FDA 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 Regulation
A photo of a makeup brush dipped in pink eyeshadow, representing the Cosmetics Act.

Lawmakers 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 Regulation
FDA sign in front of building.

FDA 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 Regulation
An illustration of drug approved under the 510(k) clearance program in a medicine cabinet.

What 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 Regulation
An illustration of a man's hands, wearing a suit and signing a petition.

Public 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 Regulation
An illustration of yellow pills in blister packaging, representing medication with a black box warning.

What 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