FDA Regulation

Top Articles on FDA Regulation

Man sitting on floor thinking about diabetes and depression

Are Diabetes and Depression Linked?

James Parker · July 19, 2018

Depression is the leading cause of disability worldwide. For diabetics, it can have a big impact on safety and self-care.

Health Features
A photo of a young woman walking down a hall to find out how stress impacts mental health.

6 Signs of Stress Impacting Mental Health

Lauren Delisle · April 1, 2019

Nearly one-third of Americans regularly experience psychological symptoms caused by stress. This Stress Awareness Month, we're sharing six signs of stress that may be affecting your mental health.

Health Features
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
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