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ASSOCIATION OF AMER. PHYS. v. U.S. FOOD AND DRUG

No. CIV.A.00-02898 (HHK).

226 F.Supp.2d 204 (2002)

ASSOCIATION OF AMERICAN, PHYSICIANS AND SURGEONS, INC., et al., Plaintiffs, v. UNITED STATES FOOD AND DRUG ADMINISTRATION, et al., Defendants.

United States District Court, District of Columbia.

October 17, 2002.

Attorney(s) appearing for the Case

Daniel E. Troy, Food & Drug Administration, Office of the Commissioner, Rockville, MD, Bertram Walter Rein, Kristina Reynolds Osterhaus, Wiley Rein & Fielding, LLP, Washington, DC, for Plaintiffs.

Michael A. Humphreys, U.S. Attorney's Office, Drake Stephen Cutini, Barbara Stradling, U.S. Department of Justice, William Barnett Schultz, Zuckerman Spaeder, LLP, Washington, DC, for Defendants.

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...

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