Quality

EMA Issues Q&A on Health-Based Exposure Limits

The European Medicines Agency released Q&A guidance on prevention of cross-contamination and setting health-based exposure limits (HBELs) for risk identification during drug manufacturing in shared facilities. Read More

FDA Issues Final Guidance on GMPs for APIs

The FDA released final guidance on its Q7 guidelines on good manufacturing practices for active pharmaceutical ingredients, using a question and answer format to clarify the document developed through the International Conference on Harmonization. Read More

FDA Officials Discuss Sentinel’s Challenges

The biggest challenge for the FDA’s 10-year-old Sentinel program for post-market safety monitoring of medical products is having to deal with a wide range of partners and data sources, according to CDER Deputy Director Robert Ball. Read More