Meeting 10-Year DSCSA Serialization Mandate Requires Industry Big Push In Final Year
HDA finds much progress to report in seventh annual Serialization Readiness Survey, but quite a lot of work remains for many drug manufacturers and distributors if they are to meet November 2023 compliance deadline.
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ICH general assembly adopts guidelines on continuous manufacturing and risk management; US FDA opens pilot project to expedite CMC reviews for products with accelerated review timelines; other recent topics include quality maturity inspections and compounding standards.
Pharmaceutical supply chains may grow less efficient and less risk prone as US government gets more involved to ensure availability of pandemic and essential medicines. But what about pediatric oncology medicines and other treatments that save lives even though they may not be considered essential?
Bristol-Myers Squibb’s Abraxis Unit, Nephron and Lupin hit with warning letters; Lupin and Jubilant 483 inspection reports posted.