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 ...
Regulatory Affairs Professionals Society

FDA revises master protocol guidance with new section on basket trials

The US Food and Drug Administration (FDA) has revised a 2023 draft guidance on master protocols for drug and biological ...

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 ...

US FDA updates guidance to speed up drug development

June 22 (Reuters) - The U.S. Food and Drug Administration said on Monday it is launching a series of measures to speed up ...

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 ...
JD Supra

FDA Regulations to Establish Minimum CGMP Requirements for Manufacturing, Packaging, Labeling, and Holding of Dietary Supplements

On June 18, 2026, the Food and Drug Administration (“FDA”) announced the submission of a proposed collection of information ...

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.