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.
Drugmakers quickly adopt low-impact AI/ML models in quest to eventually automate manufacturing processes. Already, they are learning a lot about how these models can support their operations. One finding: innovative change management approaches may be required to unlock their full potential.