David Glazer

David Glazer

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FDA’s Shifting Stance on Public Disclosure of NDA and BLA Complete Response Letters – How Far Will It Go?

The US Food and Drug Administration has announced a renewed focus on a long-considered issue—whether FDA should release complete response letters (CRLs) issued to drug or biologic applicants. Specifically, on July 10, 2025...more

7/16/2025  /  Biosimilars , Disclosure Requirements , FDA Approval , Food and Drug Administration (FDA) , Pharmaceutical Industry , Pharmaceutical Patents , Publicly-Traded Companies , Securities and Exchange Commission (SEC) , Whistleblowers
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