FDA’s Good Review Management Practices To Debut In “Near Future”
Even as the agency wrestles with the transformation brought by FDAAA, shifts in how it processes NDAs may be the "most important," CDER official says.
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Monitoring the use of decentralized elements in clinical trials is a priority for the European medicines regulatory network.
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Pfizer told the Pink Sheet it would work with the health technology assessment institute, NICE, with the hope of making Hympavzi available to patients with hemophilia A via the National Health Service.
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The verdict by the Unified Patent Court in the dispute between Sanofi/Regeneron Pharmaceuticals and Amgen explains what companies should look out for when deciding whether infringement has taken place when it comes to second medical use patents.