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By Peter H. Calcott, Ph.D., Calcott Consulting LLC | In March 2026, the FDA issued a new draft guidance titled Responding to FDA Form 483 Observations at the Conclusion of a Drug CGMP Inspection Guidance for Industry. Let's take a closer look. | |
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By Bikash Chatterjee and CSO of Pharmatech Associates, a USP Company and USP Microbiology | Let's examine the objective measurement tools that directly address each of the gaps between Annex 1 expectations and what drug manufacturing facilities can currently demonstrate in practice. | |
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By Tatyana Matveeva, Ph.D., Massachusetts General Hospital | Many sponsors miscast preclinical development as an unglamorous step between discovery and the clinic. Here's how the consequences may lead to irrevocable losses. | |
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