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Disclosure Requirements › Biologics › Regulatory Oversight

Latham & Watkins LLP

FDA Publishes Complete Response Letters for Unapproved Drug Applications

Latham & Watkins LLP on

On September 4, 2025, the US Food and Drug Administration (FDA or the Agency) announced that it released a second batch of complete response letters (CRLs) — which explain the Agency’s determination for refusing to approve a...more

Orrick, Herrington & Sutcliffe LLP

FDA’s “Radical Transparency” Arrives: Real-Time Publication of CRLs Poses New Exposures for Innovative Pharmaceutical Companies

Orrick, Herrington & Sutcliffe LLP on

The U.S. Food and Drug Administration (FDA) has unveiled a sweeping transparency initiative that will fundamentally change how innovative drug and biologic developers interface with the Agency and the market. ...more

Hogan Lovells

FDA releasing Complete Response Letters for drugs and biologics that have not yet been approved

Hogan Lovells on

The U.S. Food and Drug Administration (FDA) is now releasing complete response letters (CRLs) for BLA and NDA products not yet approved – including CRLs associated with pending or withdrawn applications. ...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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