Trump Administration To Close Loophole And Codify Medicare Drug Price Regulations

The Trump administration is closing a loophole that drugmakers could use to avoid negotiations when they add active ingredients to drugs. It's also codifying regulations.
STAT

A former AI regulator, now in industry, says biopharma is reading FDA’s guidance wrong

Companies are being too conservative in how they interpret FDA's AI guidance, but the agency can do more to help, too, Tala ...
STAT

A ‘historic’ FDA clearance raises the question: Is the LLM an interface or the decision-maker?

The newly cleared device is based around an app that helps a patient manage their diabetes using a treatment plan defined by ...

Target baby wipes recalled for bacteria risk, but FDA didn't 'upgrade' notice

Posts claimed federal officials "upgraded" the recall to the highest level, meaning there's a "reasonable probability of ...
Regulatory Affairs Professionals Society

This Week at FDA: FDA names PreCheck participants, TAP open to all OHT devices, and more

Welcome to another installment of This Week at FDA, your weekly source for updates – big and small – on FDA, drug and medical ...

Memphis Surgeon Seeks to Overturn Conviction, Citing FDA Guidance on Medical Devices with National Experts Aghast at Overzealous Persecution Despite FDA Safe Harbor

Sworn Declarations from Former FDA Counsel and Renowned Device Regulation Expert Expose Clear Regulatory Carve-Outs for Outpatient Clinics; Emergency Motion Seeks to Strike Verdict Before July 7 ...

What a Brooklyn bodega reveals about the craze for an experimental weight-loss drug

It isn't approved by the FDA, but we found an experimental weight-loss drug called retatrutide for sale at a local ...

From caffeine to 'healthy' labeling, FDA sets year-end agenda for US food supply

The U.S. Food and Drug Administration (FDA) has announced the food supply issues it seeks to tackle by year's end.
JD Supra

FDA to Limit PFAS in Bottled Water, FDA Denies Citizen Petition for PFAS Food Tolerances, and California EPR Law Challenged.

The U.S. Food & Drug Administration (FDA) has announced plans to regulate per- and polyfluoroalkyl substances (PFAS) in bottled water. The decision stems from a requirement under the Federal Food, ...

FDA panel on peptides will include experts who promote the unproven chemicals favored by RFK Jr.

When U.S. health officials meet next month to reconsider a list of controversial peptide drugs, they will hear from a new set ...

On Nicotine, FDA Embraces Science and Delivers a Public Health Victory

The Food and Drug Administration's (FDA’s) latest decision on nicotine pouches marks one of the most important advances in ...