Category: fda

Medical Device Failures Brought To Light Now Bolster Lawsuits And Research

Millions of injuries and malfunctions once funneled into a hidden Food and Drug Administration database are now available.

No Safety Switch: How Lax Oversight Of Electronic Health Records Puts Patients At Risk

Special interests and congressional inaction blocked efforts to track the safety of electronic medical records, leaving patients at risk.

A Regulatory Haze: Vape Marketers Are Online, Creating New Headaches For Feds

The subculture around vaping has been fueled by social media, and traditional regulations don’t easily address potential pitfalls.

Flavor Bans Multiply, But Menthol Continues to Divide

As states and communities ban the sale of flavored tobacco products linked to vaping, anti-smoking activists are piggybacking on the momentum to target menthol cigarettes. But some African Americans say menthol cigarette bans will lead to discrimination.

FDA Keeps Brand-Name Drugs On A Fast Path To Market ― Despite Manufacturing Concerns

The agency approved Gilead’s “game changer” hepatitis C cure, bypassing concerns raised by its own federal inspectors.

Vapers Accuse Officials Of Overreach As Investigation Into Deadly Lung Illness Lags

With federal authorities offering few details about what is causing the deadly outbreak of vaping-related lung illnesses, vaping advocates are crafting an alternative narrative reverberating through online communities.

Skin-Lightening Cream Put A Woman Into A Coma. It Could Happen Again.

A Sacramento woman is in a coma after using a face cream from Mexico. It is the nation’s first case of methylmercury poisoning from a cosmetic, and public health officials can do almost nothing to prevent other contaminated cosmetics from hitting the shelves.

At Raucous Hearing, No Unity On Vaping Issues

A hearing before a House Oversight and Reform Committee panel on how to address the crisis of respiratory injuries related to vaping turned surprisingly partisan.

As Off-Label Use Spreads, Supplies Of Niche Drugs And Patients’ Patience Grow Short

The reasons behind one particular shortage of a therapy known as IVIG are complicated, stemming from increased demand and the medication’s long production window.

Camouflaged Vaping Devices Are Hoodwinking Parents And Schools

The vaping hoodie. The vaping watch. The vaping phone case. Each ready to deliver a puff of nicotine (or marijuana) anywhere, anytime. The vaping market is crowded with sleek, camouflaged devices that have teachers and parents struggling to monitor illicit usage of a product that has surged in popularity among high schoolers.