FDA Slaps Replidyne With Faropenem Warning

Dubious trials were done several years ago by Bayer, Replidyne tells “The Pink Sheet” DAILY.

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Advanz Pharma would have had to show that the European Commission’s decision to revoke Ocaliva’s conditional marketing approval risked causing serious and irreparable harm, according to lawyers from Van Bael & Bellis.

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Brazil Pilots Digital Drug Pack Inserts

 

A new pilot aims to take Brazil closer to ‘digital transformation.’

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AI In Manufacturing: EU To Revamp GMP Guidance In Light Of Digital Advancements

 

Pharma firms are being encouraged to respond to a European Commission consultation on planned updates to its good manufacturing practice standards which reflect the “rapid advancement” of modern technologies, like AI and digital systems, in drug manufacturing.

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US FDA Staff Stability Should Be A Congressional Priority, Former Chief Of Staff Says

 

Lawmakers should address FDA staff upheaval and help the agency “get back on track,” former agency Chief of Staff Elizabeth Jungman said, while CBER Director Vinay Prasad told staff he is asking ex-colleagues to return to the agency.