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Food and Drug Administration (FDA) Disclosure Requirements Investors

Cozen O'Connor

FDA Transparency Push: CRLs Released

Cozen O'Connor on

On July 10, 2025, citing a drive to increase transparency, the Food and Drug Administration (“FDA”) published more than 200 complete response letters (CRLs) previously issued to companies that had submitted new drug...more

King & Spalding

FDA Publishes More Than 200 Complete Response Letters (CRLs) With More to Come

King & Spalding on

On July 10, 2025, the Food and Drug Administration (FDA) announced that it had published more than 200 complete response letters (CRLs), in response to applications submitted to the FDA for approval of drugs or biological...more

Akin Gump Strauss Hauer & Feld LLP

FDA Opens the Vault on Decision Letters—Releases Wave of Drug and Biologic CRLs

This morning, the U.S. Food and Drug Administration (FDA) announced the publication of more than 200 decision letters, also known as complete response letters (CRLs), with plans to release more from the archives. The CRLs...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

ArentFox Schiff

Investigations Newsletter: Medical Technology Company President Convicted for Participation in $77 Million COVID-19 and Allergy...

ArentFox Schiff on

Medical Technology Company President Convicted for Participation in $77 Million COVID-19 and Allergy Testing Scheme - On September 1, 2022, the president of Arrayit Corporation, a medical technology company in Silicon...more

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