Regulatory Affairs Professionals Society

FDA proposes rule to ease registration for distributed manufacturers, require foreign API sites to register

The US Food and Drug Administration (FDA) on Friday outlined a set of proposed reforms to advance modern manufacturing ...
Regulatory Affairs Professionals Society

FDA plans rules to rein in drug ads, enable proactive release of CRLs, and more

The Trump administration has released its latest unified agenda, laying out the proposed and final rules its agencies plan to ...

FDA moves to expose hidden foreign drug factories, strengthen domestic production in sweeping rule proposal

The FDA's new website and regulatory overhaul aim to close a loophole that lets foreign factories hide raw drug materials from U.S. supply chain oversight.

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 drug research, from early-stage investigational studies to late-stage trials, ...
SGB Online

EXEC: Whoop Gets a Win for BPI Feature as FDA Officially Drops its Warning Letter

The U.S. Food and Drug Administration (FDA) has officially dropped its warning letter and enforcement complaint against Whoop ...
Food

FDA’s 2025 Food Agenda: What industry must know

FDA’s recently unveiled 2025 Human Foods Program guidance agenda offers a detailed view of the agency’s priorities for the year ahead. The document is non-binding, but provides critical insight into ...
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 ...

FDA drops Whoop warning letter over blood pressure feature

Whoop made changes to its blood pressure insights feature that satisfied the FDA’s requirements for wellness devices.
The Manila Times

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 Sente ...