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Disclosure Requirements Biotechnology Food and Drug Administration (FDA)

Hogan Lovells

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

Hogan Lovells on

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

Fenwick & West LLP

Clinical Data FAQs: How to Prepare for Disclosure

Fenwick & West LLP on

When it comes to disclosing clinical trial data in the biotechnology arena, in particular for public biotech companies, timing is everything. Disclosures are not just about when to reveal the information, but also what is...more

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