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Administrative Procedure Act Biologics

Ropes & Gray LLP

FDA Makes Good on Promise to Publish CRLs for Unapproved Drugs and Biologics

Ropes & Gray LLP on

On September 4, 2025, the U.S. Food and Drug Administration (“FDA”) announced plans to begin releasing complete response letters (“CRLs”) “promptly” after it issues them to sponsors, rather than waiting until after approval....more

Morgan Lewis - As Prescribed

Vaccine Suspension: FDA Leans Into Its Withdrawal Toolbox, But Will It Invite Challenges?

On August 22, 2025, FDA suspended the biologics license for Ixchiq, one of only two marketed chikungunya vaccines. The decision to suspend comes only a few weeks after FDA approved a Safety Labeling Change supplemental...more

Perkins Coie

DC Court Holds That ESA Section 7 Does Not Give the “Benefit of the Doubt” to Listed Species

Perkins Coie on

The U.S. Court of Appeals for the District of Columbia Circuit issued an opinion on June 16, 2023, speaking to several important issues in administrative law. Confronting a challenge under the Endangered Species Act (ESA),...more

WilmerHale

PTAB/USPTO Update - September 2021

WilmerHale on

USPTO Leadership - ..Drew Hirshfeld is still performing the functions and duties of Director. The Biden Administration has not made an announcement as to who will be nominated to become the next Director. ...more

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