104 Cited authorities

  1. Lujan v. Defs. of Wildlife

    504 U.S. 555 (1992)   Cited 28,020 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 16,038 times   505 Legal Analyses
    Holding that courts "must give effect to the unambiguously expressed intent of Congress"
  3. Barnhart v. Thomas

    540 U.S. 20 (2003)   Cited 4,462 times   2 Legal Analyses
    Holding that at step four, in concluding that a claimant may return to her past relevant work, an ALJ need not investigate whether that work exists in significant numbers in the national economy, noting that the inquiry into the "national economy" is reserved for step five
  4. Motor Vehicle Manufacturers Assoc. of the United States, Inc. v. State Farm Mutual Auto. Ins. Co.

    463 U.S. 29 (1983)   Cited 6,653 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 2,599 times   30 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. Christensen v. Harris County

    529 U.S. 576 (2000)   Cited 1,895 times   18 Legal Analyses
    Holding that agency interpretations contained in "policy statements, agency manuals, and enforcement guidelines, all of which lack the force of law do not warrant Chevron-style deference"
  7. Monsanto Co. v. Geertson Seed Farms

    561 U.S. 139 (2010)   Cited 1,154 times   13 Legal Analyses
    Holding that plaintiffs, alfalfa farmers, had standing based on a causal chain, though plaintiffs did not identify particular alfalfa plants that had been, or would necessarily be, pollinated by bees who carried the genetically engineered gene at issue
  8. Citizens to Preserve Overton Park v. Volpe

    401 U.S. 402 (1971)   Cited 5,976 times   8 Legal Analyses
    Holding a decision is committed to agency discretion when there is "no law to apply"
  9. Fed. Commc'ns Comm'n v. Fox Television Stations, Inc.

    556 U.S. 502 (2009)   Cited 1,052 times   21 Legal Analyses
    Holding that agencies may not change their policies "sub silentio "
  10. Baze v. Rees

    553 U.S. 35 (2008)   Cited 1,043 times   13 Legal Analyses
    Holding in the Eighth Amendment context that the government's choice of drug can violate the Constitution
  11. Rule 12 - Defenses and Objections: When and How Presented; Motion for Judgment on the Pleadings; Consolidating Motions; Waiving Defenses; Pretrial Hearing

    Fed. R. Civ. P. 12   Cited 348,046 times   927 Legal Analyses
    Granting the court discretion to exclude matters outside the pleadings presented to the court in defense of a motion to dismiss
  12. Section 706 - Scope of review

    5 U.S.C. § 706   Cited 20,507 times   185 Legal Analyses
    Granting courts jurisdiction to "compel agency action unlawfully held or unreasonably delayed"
  13. Section 701 - Application; definitions

    5 U.S.C. § 701   Cited 9,404 times   36 Legal Analyses
    Adopting the definition given in Section 551
  14. Section 355 - New drugs

    21 U.S.C. § 355   Cited 2,252 times   340 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 321 - Definitions; generally

    21 U.S.C. § 321   Cited 1,169 times   165 Legal Analyses
    Defining “new drug”
  16. Section 660 - Judicial review

    29 U.S.C. § 660   Cited 885 times   29 Legal Analyses
    Permitting review of orders of the Occupational Safety and Health Review Commission by filing a petition in a court of appeals
  17. Section 7413 - Federal enforcement

    42 U.S.C. § 7413   Cited 562 times   17 Legal Analyses
    Granting the Administrator discretion to extend the ambient air quality standard attainment date set in the 1977 Act by up to three years for steelmaking facilities
  18. Section 482 - Enforcement

    29 U.S.C. § 482   Cited 515 times
    Requiring exhaustion of internal remedies before member may file complaint with the Secretary; also providing that challenged elections shall be presumed valid pending final decision on Title IV violation
  19. Section 333 - Penalties

    21 U.S.C. § 333   Cited 439 times   39 Legal Analyses
    Defining civil and criminal penalties for violations of Section 331
  20. Section 334 - Seizure

    21 U.S.C. § 334   Cited 375 times   5 Legal Analyses
    Authorizing a libel for condemnation of adulterated and misbranded pharmaceuticals
  21. 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
  22. Section 10.85 - Advisory opinions

    21 C.F.R. § 10.85   Cited 44 times   3 Legal Analyses
    Providing that an FDA employee's written statement, which constitutes "an informal communication," "does not necessarily represent the formal position of FDA," a statement that by its terms contemplates that certain employee statements may do so
  23. Section 314.410 - Imports and exports of new drugs

    21 C.F.R. § 314.410   Cited 3 times   2 Legal Analyses

    (a)Imports. (1) A new drug may be imported into the United States if: (i) It is the subject of an approved application under this part; or (ii) it complies with the regulations pertaining to investigational new drugs under part 312; and it complies with the general regulations pertaining to imports under subpart E of part 1. (2) A drug substance intended for use in the manufacture, processing, or repacking of a new drug may be imported into the United States if it complies with the labeling exemption