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 ...

US FDA proposes rule to simplify registration for some drug manufacturers

July 10 (Reuters) - The U.S. FDA on Friday proposed a rule to streamline registration requirements for certain drug ...
JD Supra

FDA Proposes New Drug Manufacturing Rule: What Distributed Manufacturing and Foreign API Registration Changes Could Mean for Pharma Compliance

In the wake of the Food & Drug Administration’s (FDA) ambitious unified agenda, on July 13, 2026, the agency published a proposed rule aiming to ...
American Hospital Association

FDA proposes drug registration changes to boost supply chain transparency

The FDA July 10 released a proposed rule that would modernize drug establishment registration requirements, with implications ...
RAPS

FDA Warns California Drug Distributor for Listing Deficiencies

The US Food and Drug Administration (FDA) on Tuesday released a warning letter sent to Orange, CA-based distributor NuCare Pharmaceuticals after the company failed to correct certain drug listings.
Becker's Hospital Review

FDA clears Walgreens in drug listing violations case

The FDA said Walgreens has addressed violations related to drug listing deficiencies for one of its products, according to a Dec. 19 close-out letter. The agency previously cited Walgreens in ...
Medical Marketing & Media

FDA takes first step toward ‘de facto’ ad ban: What to know

The FDA has proposed a new rule that would seek to eliminate the adequate provision guidance in pharma DTC ads.