§Why CasetextPricing

Tummino et al v. Hamburg et al

MEMORANDUM & ORDER granting Plaintiffs' 2 Motion for Summary Judgment and denying Defendants' 70 Cross Motion for Summary Judgment. So Ordered

37 Cited authorities

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

    463 U.S. 29 (1983)   Cited 6,666 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]'"

  2. Citizens to Preserve Overton Park v. Volpe

    401 U.S. 402 (1971)   Cited 5,979 times   8 Legal Analyses
    Holding a decision is committed to agency discretion when there is "no law to apply"

  3. Florida Power Light Co. v. Lorion

    470 U.S. 729 (1985)   Cited 1,889 times   1 Legal Analyses
    Holding that the Hobbs Act vests in the court of appeals initial judicial review authority over an NRC order denying a petition under 10 C.F.R. § 2.206 for suspension of an operating license

  4. Securities Comm'n v. Chenery Corp.

    332 U.S. 194 (1947)   Cited 4,159 times   14 Legal Analyses
    Holding that reviewing court may consider only grounds invoked by agency

  5. Bolger v. Youngs Drug Products Corp.

    463 U.S. 60 (1983)   Cited 752 times   9 Legal Analyses
    Holding ban on "unsolicited advertisements for contraceptives" was not narrowly tailored to interest in "aiding parents' efforts to discuss birth control with their children."

  6. U.S. v. Dunkel

    927 F.2d 955 (7th Cir. 1991)   Cited 2,244 times   5 Legal Analyses
    Holding that "Judges are not like pigs, hunting for truffles buried in" the record

  7. 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

  8. 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"

  9. James Madison Ltd., by Hecht v. Ludwig

    82 F.3d 1085 (D.C. Cir. 1996)   Cited 687 times
    Holding that the right to due process did not require a hearing before the government seized banks and allowed the FDIC to liquidate the banks

  10. Watts v. Indiana

    338 U.S. 49 (1949)   Cited 584 times   3 Legal Analyses
    Holding that solitary confinement for the first two days following arrest, coupled with interrogation for five nights, intermittent daytime interrogations, no hearing before a magistrate, no advisement of constitutional rights, no counsel or professional aid and inadequate rest and food resulted in a confession secured “through the pressure of unrelenting interrogation”

  11. Section 706 - Scope of review

    5 U.S.C. § 706   Cited 20,549 times   185 Legal Analyses
    Granting courts jurisdiction to "compel agency action unlawfully held or unreasonably delayed"

  12. Section 301 - Short title

    21 U.S.C. § 301   Cited 2,431 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

  13. Section 355 - New drugs

    21 U.S.C. § 355   Cited 2,253 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 393 - Food and Drug Administration

    21 U.S.C. § 393   Cited 182 times   10 Legal Analyses
    Defining the FDA's mission

  16. 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,

  17. Section 314.3 - Definitions

    21 C.F.R. § 314.3   Cited 147 times   30 Legal Analyses
    Defining "reference listed drug"

  18. Section 10.30 - Citizen petition

    21 C.F.R. § 10.30   Cited 140 times   35 Legal Analyses
    Describing the requirements for filing a citizens' petition

  19. Section 314.520 - Approval with restrictions to assure safe use

    21 C.F.R. § 314.520   Cited 21 times   4 Legal Analyses

    (a) If FDA concludes that a drug product shown to be effective can be safely used only if distribution or use is restricted, FDA will require such postmarketing restrictions as are needed to assure safe use of the drug product, such as: (1) Distribution restricted to certain facilities or physicians with special training or experience; or (2) Distribution conditioned on the performance of specified medical procedures. (b) The limitations imposed will be commensurate with the specific safety concerns

  20. Section 314.500 - Scope

    21 C.F.R. § 314.500   Cited 12 times   3 Legal Analyses

    This subpart applies to certain new drug products that have been studied for their safety and effectiveness in treating serious or life-threatening illnesses and that provide meaningful therapeutic benefit to patients over existing treatments (e.g., ability to treat patients unresponsive to, or intolerant of, available therapy, or improved patient response over available therapy). 21 C.F.R. §314.500 57 FR 58958, Dec. 11, 1992, as amended at 64 FR 402, Jan. 5, 1999

  21. 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

  22. Section 10.20 - Submission of documents to Dockets Management Staff; computation of time; availability for public disclosure

    21 C.F.R. § 10.20   Cited 4 times   1 Legal Analyses

    (a) A submission to the Dockets Management Staff of a petition, comment, objection, notice, compilation of information, or any other document is to be filed in four copies except as otherwise specifically provided in a relevant FEDERAL REGISTER notice or in another section of this chapter. The Dockets Management Staff is the agency custodian of these documents. (b) A submission is to be signed by the person making it, or by an attorney or other authorized representative of that person. Submissions