48 Cited authorities

  1. Lujan v. Defs. of Wildlife

    504 U.S. 555 (1992)   Cited 28,078 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. Chevron U.S.A. v. Natural Res. Def. Council

    467 U.S. 837 (1984)   Cited 16,042 times   505 Legal Analyses
    Holding that courts "must give effect to the unambiguously expressed intent of Congress"
  3. Warth v. Seldin

    422 U.S. 490 (1975)   Cited 11,935 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. Powers v. Ohio

    499 U.S. 400 (1991)   Cited 2,559 times   4 Legal Analyses
    Holding that a white defendant has standing to challenge strikes of black jurors
  5. Arlington Heights v. Metropolitan Housing Corp.

    429 U.S. 252 (1977)   Cited 4,313 times   8 Legal Analyses
    Holding that plaintiffs need show only that "a discriminatory purpose has been a motivating factor in the decision," because, after all, "[r]arely can it be said that a legislature or administrative body operating under a broad mandate made a decision motivated solely by a single concern, or even that a particular purpose was the ‘dominant’ or ‘primary’ one."
  6. FW/PBS, Inc. v. City of Dallas

    493 U.S. 215 (1990)   Cited 2,378 times   2 Legal Analyses
    Holding that the burden is on the plaintiff to allege facts sufficient to establish jurisdiction (quoting McNutt v. General Motors Acceptance Corp., 298 U.S. 178, 189 (1936))
  7. O'Shea v. Littleton

    414 U.S. 488 (1974)   Cited 4,109 times   5 Legal Analyses
    Holding that "[p]ast exposure to illegal conduct does not in itself show a present case or controversy regarding injunctive relief ... if unaccompanied by any continuing, present adverse effects"
  8. Simon v. E. Ky. Welfare Rights Org.

    426 U.S. 26 (1976)   Cited 3,196 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
  9. Singleton v. Wulff

    428 U.S. 106 (1976)   Cited 2,715 times   2 Legal Analyses
    Holding that federal appellate courts may raise issues sua sponte where "injustice might otherwise result"
  10. Havens Realty Corp. v. Coleman

    455 U.S. 363 (1982)   Cited 2,039 times   14 Legal Analyses
    Holding that an organization suffers injury in fact when its key activities are "perceptibly impaired" and its resources "consequent[ly] drain[ed]"
  11. Section 702 - Right of review

    5 U.S.C. § 702   Cited 7,101 times   25 Legal Analyses
    Granting judicial review of "agency action"
  12. Section 704 - Actions reviewable

    5 U.S.C. § 704   Cited 4,276 times   31 Legal Analyses
    Granting judicial review over " final agency action"
  13. Section 3604 - Discrimination in the sale or rental of housing and other prohibited practices

    42 U.S.C. § 3604   Cited 4,107 times   64 Legal Analyses
    Requiring any "accommodation" in "rules, policies, practices, or services" to be "reasonable"
  14. Section 355 - New drugs

    21 U.S.C. § 355   Cited 2,252 times   341 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"
  15. Section 3612 - Enforcement by Secretary

    42 U.S.C. § 3612   Cited 565 times   1 Legal Analyses
    Authorizing fee entitlement only for "plaintiffs"
  16. Section 353 - Exemptions and consideration for certain drugs, devices, and biological products

    21 U.S.C. § 353   Cited 300 times   20 Legal Analyses
    Requiring a prescription drug label to bear the symbol "Rx only"
  17. Section 314.50 - Content and format of an NDA

    21 C.F.R. § 314.50   Cited 150 times   16 Legal Analyses
    Recognizing the proprietary nature of DSD and SP specifications by requiring that each ANDA applicant provide its own distinct specifications
  18. Section 10.25 - Initiation of administrative proceedings

    21 C.F.R. § 10.25   Cited 77 times   3 Legal Analyses
    Including forms under 21 C.F.R. § 314.50 among the forms that constitute a "petition"
  19. Section 10.45 - Court review of final administrative action; exhaustion of administrative remedies

    21 C.F.R. § 10.45   Cited 48 times   1 Legal Analyses
    Providing that " request that the Commissioner take or refrain from taking any form of administrative action must first be the subject of a final administrative decision based on a petition submitted under § 10.25 . . . before any legal action is filed in a court complaining of the action or failure to act"
  20. Section 314.125 - Refusal to approve an NDA

    21 C.F.R. § 314.125   Cited 42 times   3 Legal Analyses
    Requiring FDA to reject application when proposed labeling is "false or misleading in any particular"
  21. Section 314.71 - Procedures for submission of a supplement to an approved application

    21 C.F.R. § 314.71   Cited 12 times   2 Legal Analyses

    (a) Only the applicant may submit a supplement to an application. (b) All procedures and actions that apply to an application under § 314.50 also apply to supplements, except that the information required in the supplement is limited to that needed to support the change. A supplement is required to contain an archival copy and a review copy that include an application form and appropriate technical sections, samples, and labeling; except that a supplement for a change other than a change in labeling

  22. Section 310.200 - Prescription-exemption procedure

    21 C.F.R. § 310.200   Cited 11 times   2 Legal Analyses

    (a)Duration of prescription requirement. Any drug limited to prescription use under section 503(b)(1)(B) of the act remains so limited until it is exempted as provided in paragraph (b) or (e) of this section. (b)Prescription-exemption procedure for drugs limited by a new drug application. Any drug limited to prescription use under section 503(b)(1)(B) of the act shall be exempted from prescription-dispensing requirements when the Commissioner finds such requirements are not necessary for the protection

  23. Section 310.201 - Exemption for certain drugs limited by new-drug applications to prescription sale

    21 C.F.R. § 310.201

    (a) The prescription-dispensing requirements of section503(b)(1)(B) of the Federal Food, Drug, and Cosmetic Act are not necessary for the protection of the public health with respect to the following drugs subject to new drug applications: (1)N -Acetyl-p-aminophenol (acetaminophen, p-hydroxy-acetanilid) preparations meeting all the following conditions: (i) The N-acetyl-p-aminophenol is prepared, with or without other drugs, in tablet or other dosage form suitable for oral use in self-medication