Regulatory Affairs Professionals Society

FDA warns three firms for GMP violations, cites Incyte for misleading claims

The US Food and Drug Administration (FDA) recently issued three warning letters to facilities in China, the US, and India for ...
BioSpace

UCSF, Par Health hit with FDA warning letters for environmental monitoring issues

FDA inspectors warned UCSF radiopharmaceutical facility that losing environmental control could pose a serious hazard to ...
RAPS

FDA warning letters target two firms in India for GMP violations, US sponsor for BIMO violations

The US Food and Drug Administration (FDA) sent warning letters to an active pharmaceutical ingredient (API) supplier and a pharmaceutical company in India for violating current good manufacturing ...
Hosted on MSN

FDA sends warning letter to maker of Ozempic, Wegovy over unreported potential GLP-1 side effects

The U.S. Food and Drug Administration sent a warning letter this month to Novo Nordisk, the maker of Ozempic and Wegovy, alleging the drugmaker failed to report potential side effects in patients who ...
Nasdaq

Integra LifeSciences reports FDA warning letter related to quality system issues

In a regulatory filing on Monday, Integra LifeSciences (IART) said that on December 19, 2024, a subsidiary received a warning letter from the U.S. FDA. The warning letter relates to quality system ...
Hosted on MSN

ImmunityBio founder pushes back after FDA warning letter over Anktiva claims — says ad never aired at all

・The FDA warning letter cited both the TV ad and Soon-Shiong’s earlier appearance on The Sean Spicer Show as suggesting uses beyond Anktiva’s approved indication. ・Soon-Shiong said the FDA classified ...