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
Some filling lines and API plants fared poorly in post-pandemic inspections, with shortfalls identified in sterility assurance and impurity control. Zhejiang Tianyu and System Kosmetik got warning letters. Alvotech, Cipla and Aurobindo got Form 483 reports posted on the FDA website.
Responses to FDA draft guidance suggest more promptness while also more elaborate processes for agency decision making based on remote methods. Questions include what’s voluntary, what’s mandatory, what can be decided remotely, and how to remotely move on from warning letters.