Legal Opinion
Vanda Pharmaceuticals, Inc. v. Food and Drug Administration
District Court, District of Columbia
Decided January 31, 2020No. Civil Action No. 2019-0301Published
1Opinion of the Court
UNITED STATES DISTRICT COURT FOR THE DISTRICT OF COLUMBIA VANDA PHARMACEUTICALS, INC., et al., Plaintiffs, v. Civil No. 19-301 (JDB) FOOD AND DRUG ADMINISTRATION, et al., 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 until the drug’s sponsor, plaintiff Vanda Pharmaceuticals, Inc., conducted a long-term toxicity study on nonrodent animals. Vanda filed this…
2Cases cited41 opinions
- Motor Vehicle Mfrs. Assn. of United States, Inc. v. State Farm Mut. Automobile Ins. Co.Supreme Court of the United States · 1983
- Baltimore Gas & Electric Co. v. Natural Resources Defense Council, Inc.Supreme Court of the United States · 1983
- Kisor v. WilkieSupreme Court of the United States · 2019
- Pension Benefit Guaranty Corporation v. LTV Corp.Supreme Court of the United States · 1990
- Shalala v. Guernsey Memorial HospitalSupreme Court of the United States · 1995
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