Axsome Is Latest To Falter With Technology For Unlocking Meloxicam’s Analgesic Potential
Axsome’s CRL was not the first from the US FDA for the nearly insoluble NSAID as sponsors try different technologies for delivering its pain relief quickly.
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Keeping Track: AZ’s Busy Oncology Biz, Phathom’s Voquezna Approval, And A Trio Of Complete Response Letters
The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker
Draft guidance on redundancy risk management plans layers risk-based expectations over new statutory requirements to plan more resilient supply chains for critical drugs.
Agency’s revised OOS guidance clarifies positions on outlier test results, averaging of HPLC results and some finer points around OOS questions. These could marginally improve compliance but won’t impact industry with nearly the force of the original 2006 guidance or the 1993 court ruling that preceded it.