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VANDA PHARMACEUTICALS v. FOOD AND DRUG ADMIN.

Civil No. 19-301 (JDB).

436 F.Supp.3d 256 (2020)

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

United States District Court, District of Columbia.

Signed January 31, 2020.

Editors Note
Applicable Law: 05 U.S.C. § 0706
Cause: 05 U.S.C. § 0706 Judicial Review of Agency Actions
Nature of Suit: 890 Other Statutory Actions
Source: PACER

Attorney(s) appearing for the Case

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

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

MEMORANDUM OPINION

In December 2018, the Food and Drug Administration placed a partial clinical hold on long-term human testing of the drug tradipitant. The hold was based on FDA's conclusion that it could not properly assess the risks of long-term tradipitant use in humans...

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