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Securities Litigation › Regulatory Oversight › Food and Drug Administration (FDA)

Skadden, Arps, Slate, Meagher & Flom LLP

FDA Pivots on Publishing Complete Response Letters, Raising SEC Disclosure and Securities Litigation Implications

Skadden, Arps, Slate, Meagher & Flom LLP on

On July 10, 2025, the U.S. Food and Drug Administration (FDA) announced that it was embracing “radical transparency” by publishing more than 200 Complete Response Letters (CRLs) — letters the agency issues to a sponsor when...more

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

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