Tales From CMC Reviews: Norliqva, Hydroxychloroquine, Glycopyrrolate And Sotyktu
Insights from US drug approval packages include how CMP Development navigated inspection challenges, how Novitium built a better scientific bridge, how Fresenius Kabi delivered on leachables & extractables, and how BMS addressed dissolution.
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Keeping Track: Terliprez, Sotyktu Keep Up US FDA’s Novel Approvals Pace; Submissions By Pfizer, Chiesi And BioLineRx
The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker
Broad agreement across US FDA on modified PQRI recommendations could reduce approval delays over risk of chemicals leaching into parenteral drugs.
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.