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VANDA PHARMACEUTICALS, INC. v. FOOD & DRUG ADMIN.

Civil Action No. 19-301 (JDB).

539 F.Supp.3d 44 (2021)

VANDA PHARMACEUTICALS, INC., et al., Plaintiffs, v. FOOD & DRUG ADMINISTRATION, et al., Defendants.

United States District Court, District of Columbia.

Signed May 6, 2021.

Attorney(s) appearing for the Case

Andrew A. Lyons-Berg, Michael Branch Kimberly, Paul Whitfield Hughes, III, McDermott Will & Emery LLP, Washington, DC, for Plaintiff Vanda Pharmaceuticals, Inc.

Andrew A. Lyons-Berg, Paul Whitfield Hughes, III, McDermott Will & Emery LLP, Washington, DC, for Plaintiffs December Guzman, Cathy Hartwig, Louisa Jenness.

James William Harlow, David Michael Morrell, U.S. Department of Justice, Washington, DC, for Defendants.

MEMORANDUM OPINION

The underlying dispute in this case involved plaintiff Vanda Pharmaceuticals, Inc.'s ("Vanda") challenge under the Administrative Procedure Act ("APA") to the Food and Drug Administration's ("FDA") partial clinical hold on Vanda's human testing of the...

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