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Natural Resources Defense Council, Inc. v. United States Food and Drug Administration et al

MEMORANDUM OF LAW in Support re: 15 MOTION for Summary Judgment. and opposition to plaintiff's motion for summary judgment. Document

63 Cited authorities

  1. Lujan v. Defs. of Wildlife

    504 U.S. 555 (1992)   Cited 27,821 times   138 Legal Analyses
    Holding that the elements of standing "must be supported in the same way as any other matter on which the plaintiff bears the burden of proof"

  2. Friends of the Earth, Inc. v. Laidlaw Envtl. Servs. (TOC), Inc.

    528 U.S. 167 (2000)   Cited 7,147 times   25 Legal Analyses
    Holding that plaintiffs who curtailed their recreational activities on a river due to reasonable concerns about the effect of pollutant discharges into that river had standing

  3. Warth v. Seldin

    422 U.S. 490 (1975)   Cited 11,861 times   14 Legal Analyses
    Holding that Article III requires plaintiffs "to establish that, in fact, the asserted injury was the consequence of the defendants' actions"

  4. Norton v. Southern Utah Wilderness Alliance

    542 U.S. 55 (2004)   Cited 1,465 times   6 Legal Analyses
    Holding that agency can be compelled to act if time period is specified by law

  5. Simon v. E. Ky. Welfare Rights Org.

    426 U.S. 26 (1976)   Cited 3,185 times   6 Legal Analyses
    Holding plaintiffs who sued IRS lacked standing where they hoped reversal of IRS rule would " ‘discourage’ hospitals from denying their services to" plaintiffs, but whether hospitals had denied services based on the existing rule remained unclear and, even if the rule were reversed, hospitals would remain free to not provide services to plaintiffs

  6. Heckler v. Chaney

    470 U.S. 821 (1985)   Cited 2,039 times   20 Legal Analyses
    Holding that a statute did not provide meaningful standards because it did not "speak to the criteria which shall be used by the agency for investigating possible violations of the [statute]"

  7. Sierra Club v. Morton

    405 U.S. 727 (1972)   Cited 2,781 times   3 Legal Analyses
    Holding that plaintiff-organization did not establish Article III standing for injunctive relief where the organization failed to show that its members would be affected by the actions it sought to enjoin

  8. Northeastern Florida Chapter of the Associated General Contractors of America v. City of Jacksonville

    508 U.S. 656 (1993)   Cited 1,032 times   1 Legal Analyses
    Holding contractors suing over the set-aside of certain state contracts based on race had standing to advance an equal protection claim because they were "able and ready" to bid on the contracts

  9. Vermont Yankee Nuclear Power Corp. v. Natural Resources Defense Council, Inc.

    435 U.S. 519 (1978)   Cited 1,757 times   5 Legal Analyses
    Holding that where rulemaking fulfills basic APA standards for notice and procedure, a court will not impose additional process

  10. Camp v. Pitts

    411 U.S. 138 (1973)   Cited 1,961 times   1 Legal Analyses
    Holding that "the focal point for judicial review" of whether agency action is arbitrary and capricious "should be the administrative record already in existence, not some new record made initially in the reviewing court"

  11. Section 706 - Scope of review

    5 U.S.C. § 706   Cited 20,433 times   184 Legal Analyses
    Granting courts jurisdiction to "compel agency action unlawfully held or unreasonably delayed"

  12. Section 553 - Rule making

    5 U.S.C. § 553   Cited 4,089 times   145 Legal Analyses
    Exempting "interpretative rules," among other things, from the notice-and-comment requirement

  13. Section 355 - New drugs

    21 U.S.C. § 355   Cited 2,244 times   337 Legal Analyses
    Granting the court discretion to change the date on which an ANDA may be approved if "either party to the action failed to reasonably cooperate in expediting the action"

  14. Section 321 - Definitions; generally

    21 U.S.C. § 321   Cited 1,166 times   161 Legal Analyses
    Defining “new drug”

  15. Section 353 - Exemptions and consideration for certain drugs, devices, and biological products

    21 U.S.C. § 353   Cited 298 times   20 Legal Analyses
    Requiring a prescription drug label to bear the symbol "Rx only"

  16. Section 332 - Injunction proceedings

    21 U.S.C. § 332   Cited 268 times   6 Legal Analyses
    Granting the district court jurisdiction to restrain violations of FDCA

  17. Section 330.10 - Procedures for classifying OTC drugs as generally recognized as safe and effective and not misbranded, and for establishing monographs

    21 C.F.R. § 330.10   Cited 52 times   2 Legal Analyses
    Subjecting "[a]ny product which fails to conform to an applicable monograph" to regulatory action

  18. Section 330.1 - General conditions for general recognition as safe, effective and not misbranded

    21 C.F.R. § 330.1   Cited 28 times   5 Legal Analyses
    Incorporating 21 C.F.R. § 201.66

  19. Section 310.502 - Certain drugs accorded new drug status through rulemaking procedures

    21 C.F.R. § 310.502   Cited 14 times

    (a) The drugs listed in this paragraph (a) have been determined by rulemaking procedures to be new drugs within the meaning of section 201(p) of the Federal Food, Drug, and Cosmetic Act. An approved new drug application under section 505 of the Federal Food, Drug, and Cosmetic Act and part 314 of this chapter is required for marketing the following drugs: (1) Aerosol drug products for human use containing 1,1,1-trichloroethane. (2) Aerosol drug products containing zirconium. (3) Amphetamines (amphetamine

  20. Section 330.12 - Status of over-the-counter (OTC) drugs previously reviewed under the Drug Efficacy Study (DESI)

    21 C.F.R. § 330.12   Cited 3 times

    (a) There were 420 OTC drugs reviewed in the Drug Efficacy Study (a review of drugs introduced to the market through new drug procedures between 1938 and 1962). A careful review has been made of the reports on these drugs to determine those drugs for which implementation may be deferred without significant risk to the public health, pending review by appropriate OTC drug advisory review panels and promulgation of a monograph. (b) On and after April 20, 1972, a number of notices were published in

  21. Section 310.545 - Drug products containing certain active ingredients offered over-the-counter (OTC) for certain uses

    21 C.F.R. § 310.545   Cited 2 times   3 Legal Analyses

    (a) A number of active ingredients have been present in OTC drug products for various uses, as described below. However, based on evidence currently available, there are inadequate data to establish general recognition of the safety and effectiveness of these ingredients for the specified uses: (1)Topical acne drug products. Alcloxa Alkyl isoquinolinium bromide Aluminum chlorohydrex Aluminum hydroxide Benzocaine Benzoic acid Boric acid Calcium polysulfide Calcium thiosulfate Camphor Chloroxylenol

  22. Section 250.250 - Hexachlorophene, as a component of drug and cosmetic products

    21 C.F.R. § 250.250   Cited 1 times

    (a)Antibacterial component. The use of hexachlorophene as an antibacterial component in drug and cosmetic products has expanded widely in recent years. It is used in such products because of its bacteriostatic action against gram-positive organisms, especially against strains of staphylococcus; however, hexachlorophene offers no protection against gram-negative infections. In addition the antibacterial activity depends largely on repeated use. A notice published in the FEDERAL REGISTER of April 4

  23. Section 14.100 - List of standing advisory committees

    21 C.F.R. § 14.100

    Standing advisory committees and the dates of their establishment are as follows: (a)Office of the Commissioner - (1)Science Board to the Food and Drug Administration. (i) Date established: June 26, 1992. (ii) Function: The board shall provide advice primarily to the agency's Senior Science Advisor and, as needed, to the Commissioner and other appropriate officials on specific complex and technical issues as well as emerging issues within the scientific community in industry and academia. Additionally