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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
Spain’s Agency of Medicines and Medical Devices has suspended the manufacturing authorization for finished processing of Madrid-based Inmunotek over GMP deficiencies. Read More
Sen. Claire McCaskill (D-Mo.) is taking the FDA to task for its delayed reaction in targeting companies marketing supplements containing oxilofrine, a stimulant banned by the World Anti-Doping Agency for athletes. Read More