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Cynthia Schnedar, director of CDER’s Office of Compliance, stepped down from her role on March 18 to take an unspecified private sector job, according to an email from CDER Director Janet Woodcock. Tom Cosgrove, who until recently served as director of the OC’s Office of Manufacturing Quality, assumed her position on April 4. Read More
There is a strong correlation between a surge in warning letters over data integrity issues and increased FDA inspections of manufacturers in India and China — one that could cause production headaches for U.S. drugmakers partnering with these facilities. Read More
Drugmakers selling into the EU will have two years to begin complying with a new set of ISO global standards that will create a unique identifier for drugs. Read More
The FDA is continuing its crackdown on Chinese drugmakers, adding three more companies this week to its import alert lists over faulty GMP practices and a refusal for inspection. Read More