PDA Publishes Revised Technical Report No. 56: A Clear, Phase Appropriate Roadmap for GMP Compliant Development of Biological Drug Substances

PDA Publishes Revised Technical Report No. 56: A Clear, Phase Appropriate Roadmap for GMP Compliant Development of Biological Drug Substances Technical Report No. 56 (Revised 2026) outlines a ...

FDA Foreign Inspection Gap Grows as U.S. Drug Imports Surge, New Study Finds

Foreign facilities failed FDA GMP inspections at up to 1.8x the U.S. rate. Journal of Pharmaceutical Innovation study ...
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Ukraine’s drug supply at risk as GMP delays stall imports during wartime shortages

Companies report that overly complex procedures for confirming compliance with Good Manufacturing Practices (GMP) are delaying imports and could lead to dangerous gaps in supply. Amid wartime ...
Morningstar

Esco Aster Signs Exosome Clinical cGMP Manufacturing Contract With Shine-On Biomedical For A Novel First-In-Class HLA-G Targeting Exosome Drug Delivery Platform

Esco Aster Signs Exosome Clinical cGMP Manufacturing Contract With Shine-On Biomedical For A Novel First-In-Class HLA-G Targeting Exosome Drug Delivery Platform Esco Aster, a vertically integrated ...