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Disclosure Requirements › Biologics › Food and Drug Administration (FDA)

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

Akin Gump Strauss Hauer & Feld LLP

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

Akin Gump Strauss Hauer & Feld LLP on

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

“Advancing Real-World Evidence Program” offers drug sponsors early FDA meeting opportunity

Hogan Lovells on

FDA has announced the Advancing Real-World Evidence (RWE) Program, which aims to improve the quality and acceptability of RWE-based approaches that can meet regulatory requirements in support of labeling for effectiveness...more

Mintz - Health Care Viewpoints

Are HCT/Ps a Dark Spot in the Sunshine Act Requirements?

Mintz - Health Care Viewpoints on

On February 22, the Wall Street Journal published an article about the tissue graft manufacturer MiMedx Goup, Inc. and its failure to report payments to physicians under CMS’s Open Payments Program established by the Centers...more

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