Legal Opinion
Association of American, Physicians & Surgeons, Inc. v. United States Food & Drug Administration
District Court, District of Columbia
Decided October 17, 2002No. CIV.A.00-02898 (HHK)PublishedCited by 8 opinions
1Opinion of the Court
MEMORANDUM OPINION
KENNEDY, District Judge.
Plaintiffs, Association of American Physicians and Surgeons (“AAPS”), Competitive Enterprise Institute (“CEI”), and Consumer Alert, bring this lawsuit to challenge the authority of the United States Food and Drug Administration (“FDA”) to promulgate “Regulations Requiring Manufacturers to Assess the Safety and Effectiveness of New Drugs and Biological Products in Pediatric Patients” (“Pediatric Rule”), 21 C.F.R. §§ 201, 312, 314, 601, 63 Fed.Reg. 66,632 (Dec. 2, 1998). Plaintiffs claim that the Pediatric Rule exceeds the FDA’s statutory authority and…
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- Udall v. TallmanSupreme Court of the United States · 1965
- United States v. Mead Corp.Supreme Court of the United States · 2001
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