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GMP News

FDA Updates how it Evaluates and Inspects Human Drug Facilities

Behind the FDA's new ConOps 2.0 is a sharper division of labor between CDER and OII, and new tools that make remote assessments and foreign inspection reports count toward facility decisions. Read what manufacturers need to know now.

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Cross-Contamination: The Particular Risk Posed by Beta-Lactam Antibiotics

Citing 21 CFR 211.42(c), the FDA criticised a drug manufacturer in a Warning Letter for cross-contamination with beta-lactam antibiotics. What did the FDA object to in this regard?

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EMA Procedural Advice Updates: Centralised Procedure

The European Medicines Agency (EMA) has updated its procedural advice documents for the centralised marketing authorisation procedure. The pre-authorisation and post-authorisation versions provide applicants and marketing authorisation holders with key requirements and practical procedural guidance in question-and-answer form. In parallel, the agency has updated several topic-specific Q&A pages.

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