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SEIFE v. UNITED STATES FOOD & DRUG ADMINISTRATION

Docket No. 20-4072-cv August Term 2021.

43 F.4th 231 (2022)

Charles SEIFE, Plaintiff-Appellant, v. UNITED STATES FOOD AND DRUG ADMINISTRATION, United States Department of Health and Human Services, Defendants-Appellees, and Sarepta Therapeutics, Inc., Intervenor-Defendant-Appellee.

United States Court of Appeals, Second Circuit.

Decided: August 5, 2022.

Attorney(s) appearing for the Case

Jared Carter ( Cortelyou C. Kenney , Tyler Valeska , on the brief), First Amendment Clinic, Cornell Law School, Ithaca, NY, and Thomas S. Leatherbury , Vinson & Elkins LLP, Dallas, TX, and David A. Schulz , Media Freedom & Information Access Clinic, Yale Law School, New Haven, CT, for Plaintiff-Appellant.

Dominika Tarcynska , Assistant United States Attorney ( Benjamin H. Torrance , Assistant United States Attorney, on the brief), for Audrey Strauss , United States Attorney for the Southern District of New York, New York, NY, for Defendants-Appellees.

Kristen E. Ittig ( Daniel R. Bernstein , Stuart W. Turner , Amanda J. Sherwood , and Aime Joo , on the brief), Arnold & Porter Kaye Scholer LLP, Washington, DC, and New York, NY, for Intervenor-Defendant-Appellee.

Before: Chin, Lohier, and Robinson, Circuit Judges.

In this case, intervenor-defendant-appellee Sarepta Therapeutics, Inc. ("Sarepta") obtained accelerated approval from defendant-appellee the Food and Drug Administration (the "FDA") for a drug Sarepta created to treat a neuromuscular disease. During the approval process, which spanned some nine years, Sarepta submitted tens...

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