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 ...
RAPS

FDA revises compliance guide on pre-approval inspections

The US Food and Drug Administration (FDA) revised its compliance program guide (CPG) for preapproval inspections (PAIs) for new drugs. This update emphasizes a risk-based approach to making decisions ...
JD Supra

FDA's New One-Day Inspection Pilot: More Efficient Oversight or More Questions Than Answers?

The U.S. Food and Drug Administration (FDA) recently announced a pilot program for "One-Day Inspectional Assessments," a new ...
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 ...

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.
The National Law Review

FDA Plans to Extend Compliance Date for Food Traceability Rule

We collaborate with the world's leading lawyers to deliver news tailored for you. Sign Up for any (or all) of our 25+ Newsletters. Some states have laws and ethical rules regarding solicitation and ...
STAT

FDA declares Novo Nordisk plant, key to drug manufacturing for some biotechs, out of compliance

Elaine’s stories explore the boom in new obesity treatments, new drug payment models, the ways companies are affected by FDA changes, and the emerging psychedelics drug sector. She co-writes The ...