§Why CasetextPricing

Tummino et al v. Hamburg et al

MOTION for Preliminary Injunction and Summary Judgment

27 Cited authorities

  1. United States v. Diebold, Inc.

    369 U.S. 654 (1962)   Cited 11,312 times
    Holding that a court must construe all inferences and ambiguities against the movant and in favor of the non-moving party in determining whether a genuine issue of material act has been raised

  2. Marsh v. Oregon Natural Resources Council

    490 U.S. 360 (1989)   Cited 2,004 times   2 Legal Analyses
    Holding that courts must defer to the "informed discretion" of federal agencies where the agencies’ decisions require "a high level of technical expertise" (quoting Kleppe v. Sierra Club , 427 U.S. 390, 412, 96 S.Ct. 2718, 49 L.Ed.2d 576 (1976) )

  3. Carey v. Population Services International

    431 U.S. 678 (1977)   Cited 842 times   3 Legal Analyses
    Holding that a provider of contraceptives could bring a derivative constitutional challenge on behalf of potential customers

  4. INS v. Yueh-Shaio Yang

    519 U.S. 26 (1996)   Cited 222 times   1 Legal Analyses
    Holding that once an agency announces and follows a general policy, "an irrational departure from that policy (as opposed to an avowed alteration of it) could constitute action that must be overturned as 'arbitrary, capricious, [or] an abuse of discretion' within the meaning of the Administrative Procedure Act"

  5. Spinelli v. City of New York

    579 F.3d 160 (2d Cir. 2009)   Cited 400 times
    Holding that predeprivation process was not required to suspend gun dealer's license where there were security lapses at the gun store, given the interest in public safety

  6. Atchison, T. S. F. R. Co. v. Wichita Bd. of Trade

    412 U.S. 800 (1973)   Cited 360 times
    Holding that an agency abuses its discretion by not offering adequate explanation for its failure to follow its own precedent

  7. N.Y. St. Nat. Organization for Women v. Terry

    886 F.2d 1339 (2d Cir. 1989)   Cited 650 times
    Holding that coercive sanctions should be paid to court and modifying contempt order accordingly

  8. Miner v. Clinton Cnty., N.Y

    541 F.3d 464 (2d Cir. 2008)   Cited 324 times
    Holding that this inquiry is objective, not subjective

  9. Globalnet Financial.com v. Frank Crystal Co.

    449 F.3d 377 (2d Cir. 2006)   Cited 243 times
    Holding that a state did not have the greatest interest in a tort arising from an insurance relationship merely because the ultimate insurance risk would be borne in that state

  10. Doninger v. Niehoff

    527 F.3d 41 (2d Cir. 2008)   Cited 206 times   3 Legal Analyses
    Holding Tinker applies to speech originating off-campus if it “would foreseeably create a risk of substantial disruption within the school environment, at least when it was similarly foreseeable that the off-campus expression might also reach campus”

  11. Rule 56 - Summary Judgment

    Fed. R. Civ. P. 56   Cited 330,074 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 20,530 times   185 Legal Analyses
    Granting courts jurisdiction to "compel agency action unlawfully held or unreasonably delayed"

  13. 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"

  14. 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"

  15. Section 355c - Research into pediatric uses for drugs and biological products

    21 U.S.C. § 355c   Cited 11 times   2 Legal Analyses

    (a) New drugs and biological products (1) In general (A) General requirements Except with respect to an application for which subparagraph (B) applies, a person that submits, on or after September 27, 2007, an application (or supplement to an application) for a drug- (i) under section 355 of this title for a new active ingredient, new indication, new dosage form, new dosing regimen, or new route of administration; or (ii) under section 262 of title 42 for a new active ingredient, new indication,

  16. 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

  17. 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