§Why CasetextPricing

Prevor v. United States Food and Drug Administration

MOTION for Summary Judgment

53 Cited authorities

  1. Anderson v. Liberty Lobby, Inc.

    477 U.S. 242 (1986)   Cited 236,142 times   38 Legal Analyses
    Holding that summary judgment is not appropriate if "the dispute about a material fact is ‘genuine,’ that is, if the evidence is such that a reasonable jury could return a verdict for the nonmoving party"

  2. Chevron U.S.A. v. Natural Res. Def. Council

    467 U.S. 837 (1984)   Cited 16,016 times   501 Legal Analyses
    Holding that courts "must give effect to the unambiguously expressed intent of Congress"

  3. Fed. Deposit Ins. v. Meyer

    510 U.S. 471 (1994)   Cited 7,003 times   1 Legal Analyses
    Holding a Bivens claim does not lie against federal agencies because, if damages claims were permitted against federal agencies, "there would be no reason for aggrieved parties to bring damages actions against individual officers" and thus "the deterrent effects of the Bivens remedy would be lost"

  4. Motor Vehicle Manufacturers Assoc. of the United States, Inc. v. State Farm Mutual Auto. Ins. Co.

    463 U.S. 29 (1983)   Cited 6,629 times   50 Legal Analyses
    Holding that " `settled course of behavior embodies the agency's informed judgment that, by pursuing that course, it will carry out the policies [of applicable statutes or regulations]'"

  5. United States v. Mead Corp.

    533 U.S. 218 (2001)   Cited 2,592 times   29 Legal Analyses
    Holding that a Customs classification ruling "has no claim to judicial deference under Chevron " but can "claim respect according to its persuasiveness"

  6. Food & Drug Administration v. Brown & Williamson Tobacco Corp.

    529 U.S. 120 (2000)   Cited 1,504 times   40 Legal Analyses
    Holding that Congress had not yet empowered the FDA to regulate tobacco products

  7. Fed. Commc'ns Comm'n v. Fox Television Stations, Inc.

    556 U.S. 502 (2009)   Cited 1,043 times   21 Legal Analyses
    Holding that agencies may not change their policies "sub silentio "

  8. Astoria Federal S. L. Ass'n. v. Solimino

    501 U.S. 104 (1991)   Cited 1,252 times   10 Legal Analyses
    Holding that where a plaintiff must exhaust state administrative proceedings to bring federal claims, the administrative adjudication lacks res judicata effect, as an exception to the default rule of administrative preclusion

  9. Burlington Truck Lines v. U.S.

    371 U.S. 156 (1962)   Cited 1,944 times   3 Legal Analyses
    Holding a rule invalid under the APA where "the Commission made no findings specifically directed to the choice between two vastly different remedies with vastly different consequences to the carriers and the public . . . [and failed to] articulate any rational connection between the facts found and the choice made"

  10. Securities Comm'n v. Chenery Corp.

    318 U.S. 80 (1943)   Cited 3,724 times   15 Legal Analyses
    Holding that "an administrative order cannot be upheld unless the grounds upon which the agency acted in exercising its powers were those upon which its action can be sustained"

  11. Rule 56 - Summary Judgment

    Fed. R. Civ. P. 56   Cited 328,637 times   158 Legal Analyses
    Holding a party may move for summary judgment on any part of any claim or defense in the lawsuit

  12. 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"

  13. Section 551 - Definitions

    5 U.S.C. § 551   Cited 4,744 times   69 Legal Analyses
    Adopting the definition set out in the APA

  14. 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

  15. Section 301 - Short title

    21 U.S.C. § 301   Cited 2,427 times   48 Legal Analyses

    This chapter may be cited as the Federal Food, Drug, and Cosmetic Act. 21 U.S.C. § 301 June 25, 1938, ch. 675, §1, 52 Stat. 1040. STATUTORY NOTES AND RELATED SUBSIDIARIES EFFECTIVE DATE; POSTPONEMENT IN CERTAIN CASES Act June 23, 1939, ch. 242, §§1, 2, 53 Stat. 853, 854, provided that:"[SEC. 1] (a) The effective date of the following provisions of the Federal Food, Drug, and Cosmetic Act is hereby postponed until January 1, 1940: Sections 402(c) [342(c) of this title]; 403(e)(1) [343(e)(1) of this

  16. Section 321 - Definitions; generally

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

  17. Section 360 - Registration of producers of drugs or devices

    21 U.S.C. § 360   Cited 405 times   28 Legal Analyses
    Exempting licensed healthcare practitioners engaged in certain activities from the FDCA's registration requirements

  18. 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"

  19. Section 3.2 - Definitions

    21 C.F.R. § 3.2   Cited 10 times   11 Legal Analyses
    Defining "mode of action"

  20. Section 10.75 - Internal agency review of decisions

    21 C.F.R. § 10.75   Cited 7 times   12 Legal Analyses

    (a) A decision of an FDA employee, other than the Commissioner, on a matter, is subject to review by the employee's supervisor under the following circumstances: (1) At the request of the employee. (2) On the initiative of the supervisor. (3) At the request of an interested person outside the agency. (4) As required by delegations of authority. (b) (1) The review will be made by consultation between the employee and the supervisor or by review of the administrative file on the matter, or both. The

  21. Section 3.4 - Designated agency component

    21 C.F.R. § 3.4   Cited 5 times   2 Legal Analyses

    (a) To designate the agency component with primary jurisdiction for the premarket review and regulation of a combination product, the agency shall determine the primary mode of action of the product. Where the primary mode of action is that of: (1) A drug (other than a biological product), the agency component charged with premarket review of drugs shall have primary jurisdiction; (2) A device, the agency component charged with premarket review of devices shall have primary jurisdiction; (3) A biological

  22. Section 3.7 - Request for designation

    21 C.F.R. § 3.7   Cited 2 times   1 Legal Analyses

    (a) Who should file: the sponsor of: (1) Any combination product the sponsor believes is not covered by an intercenter agreement; or (2) Any product where the agency component with primary jurisdiction is unclear or in dispute. (b) When to file: a sponsor should file a request for designation before filing any application for premarket review, whether an application for marketing approval or a required investigational notice. Sponsors are encouraged to file a request for designation as soon as there

  23. Section 3.5 - Procedures for identifying the designated agency component

    21 C.F.R. § 3.5   Cited 2 times

    (a) (1) The Center for Biologics Evaluation and Research, the Center for Devices and Radiological Health, and the Center for Drug Evaluation and Research have entered into agreements clarifying product jurisdictional issues. These guidance documents are on display in the Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852, and are entitled "Intercenter Agreement Between the Center for Drug Evaluation and Research and the Center for Devices