Eva Schifini

Eva Schifini

Hogan Lovells

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FDA’s creation of public database of 200 Complete Response letters raises questions

The U.S. Food and Drug Administration (FDA) today published more than 200 complete response letters (CRLs) issued between 2002 and 2024. FDA reports that it has only published CRLs sent to companies whose drug and biological...more

7/11/2025  /  Biotechnology , Disclosure Requirements , Food and Drug Administration (FDA) , Investors , Pharmaceutical Industry , Prescription Drugs , Regulatory Oversight , Regulatory Requirements , Securities Litigation

FDA Commissioner’s National Priority Voucher program comes with questions surrounding implementation

The U.S. Food and Drug Administration (FDA) announced Tuesday a “Commissioner’s National Priority Voucher” (CNPV) program, which will provide a “limited number” of vouchers to sponsors of drug products that are “aligned with...more

6/19/2025  /  Clinical Trials , Drug Pricing , Food and Drug Administration (FDA) , New Guidance , New Regulations , Pharmaceutical Industry , Prescription Drugs , Public Health , Regulatory Oversight , Regulatory Reform
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