§Why CasetextPricing

Ipsen Biopharmaceuticals, Inc. v. Price et al

MOTION for Summary Judgment

42 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 6,634 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. United States v. Mead Corp.

    533 U.S. 218 (2001)   Cited 2,593 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"

  3. Christensen v. Harris County

    529 U.S. 576 (2000)   Cited 1,893 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"

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

    529 U.S. 120 (2000)   Cited 1,506 times   40 Legal Analyses
    Holding that Congress had not yet empowered the FDA to regulate tobacco products

  5. Dolan v. Postal Service

    546 U.S. 481 (2006)   Cited 636 times   2 Legal Analyses
    Holding that "negligent transmission" of postal matter "does not comprehend all negligence occurring in the course of mail delivery"

  6. Encino Motorcars, LLC v. Navarro

    136 S. Ct. 2117 (2016)   Cited 371 times   18 Legal Analyses
    Holding that agency needed to provide "a more reasoned explanation for its decision to depart from its existing ... policy" in light of serious and ongoing industry reliance on prior policy when negotiating compensation packages

  7. Bedroc Ltd. v. United States

    541 U.S. 176 (2004)   Cited 509 times   1 Legal Analyses
    Holding a court presumes that Congress says in the statute what it means

  8. Chisom v. Roemer

    501 U.S. 380 (1991)   Cited 364 times
    Holding that § 2 of the VRA applies to state laws regarding election of state court judges

  9. County of Los Angeles v. Shalala

    192 F.3d 1005 (D.C. Cir. 1999)   Cited 271 times   1 Legal Analyses
    Holding that it was error for the district court to fashion a remedy for the agency to follow after declaring agency action unlawful

  10. Public Citizen, Inc. v. F.A.A

    988 F.2d 186 (D.C. Cir. 1993)   Cited 224 times   1 Legal Analyses
    Holding that the APA applies to review of FAA orders

  11. Section 706 - Scope of review

    5 U.S.C. § 706   Cited 20,443 times   184 Legal Analyses
    Granting courts jurisdiction to "compel agency action unlawfully held or unreasonably delayed"

  12. Section 355 - New drugs

    21 U.S.C. § 355   Cited 2,245 times   337 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"

  13. Section 321 - Definitions; generally

    21 U.S.C. § 321   Cited 1,167 times   163 Legal Analyses
    Defining “new drug”

  14. 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

  15. Section 1396r-8 - Payment for covered outpatient drugs

    42 U.S.C. § 1396r-8   Cited 221 times   32 Legal Analyses
    Listing as approved “compendia” the American Hospital Formulary Service Drug Information, the United States Pharmacopeia–Drug Information (or its successor publications), and the DRUGDEX Information System

  16. Section 360cc - Protection for drugs for rare diseases or conditions

    21 U.S.C. § 360cc   Cited 47 times   21 Legal Analyses
    Permitting approval of new such drug applications if the agency “finds” within the seven-year exclusivity period that the manufacturer of a drug with marketing exclusivity “cannot assure the availability of sufficient quantities of the drug to meet the needs of persons with the disease or condition for which the drug was designated” or if the manufacturer of the drug with marketing exclusivity provides its written consent to the approval of marketing applications for new such drugs within the exclusivity period

  17. Section 314.70 - Supplements and other changes to an approved NDA

    21 C.F.R. § 314.70   Cited 353 times   37 Legal Analyses
    Defining "major changes" as those "requiring supplement submission and approval prior to distribution of the product"

  18. Section 314.50 - Content and format of an NDA

    21 C.F.R. § 314.50   Cited 148 times   16 Legal Analyses
    Recognizing the proprietary nature of DSD and SP specifications by requiring that each ANDA applicant provide its own distinct specifications

  19. Section 314.1 - Scope of this part

    21 C.F.R. § 314.1   Cited 29 times

    (a) This part sets forth procedures and requirements for the submission to, and the review by, the Food and Drug Administration of applications and abbreviated applications to market a new drug under section 505 of the Federal Food, Drug, and Cosmetic Act, as well as amendments, supplements, and postmarketing reports to them. (b) This part does not apply to drug products subject to licensing by FDA under the Public Health Service Act (58 Stat. 632 as amended (42 U.S.C. 201 et seq.)) and subchapter

  20. Section 314.108 - New drug product exclusivity

    21 C.F.R. § 314.108   Cited 27 times   33 Legal Analyses

    (a)Definitions. The definitions in § 314.3 and the following definitions of terms apply to this section: Approved under section 505(b) means an NDA submitted under section 505(b) and approved on or after October 10, 1962, or an application that was "deemed approved" under section 107(c)(2) of Public Law 87-781 . Bioavailability study means a study to determine the bioavailability or the pharmacokinetics of a drug. Clinical investigation means any experiment other than a bioavailability study in which

  21. Section 447.502 - Definitions

    42 C.F.R. § 447.502   Cited 15 times   12 Legal Analyses
    Defining "estimated acquisition cost" as "the [state] agency's best estimate of the price generally and currently paid by providers for a drug marketed or sold by a particular manufacturer or labeler in the package size of drug most frequently purchased by providers"

  22. Section 207.35 - What changes require a new NDC?

    21 C.F.R. § 207.35   Cited 5 times   1 Legal Analyses

    (a) Once an NDC has been assigned by FDA, the registrant must propose a new and unique NDC for a drug when there is a change, after the drug is initially marketed, to any of the information identified in paragraphs (b) and (c) of this section. A new NDC must be proposed to FDA for assignment through an updated listing in accordance with § 207.57 . (b) The proposed new NDC must include a new product code when there is a change to any of the following information: (1) The drug's established name or

  23. Section 316.31 - Scope of orphan-drug exclusive approval

    21 C.F.R. § 316.31   Cited 4 times   6 Legal Analyses

    (a) FDA may approve a sponsor's marketing application for a designated orphan drug for use in the rare disease or condition for which the drug was designated, or for select indication(s) or use(s) within the rare disease or condition for which the drug was designated. Unless FDA previously approved the same drug for the same use or indication, FDA will not approve another sponsor's marketing application for the same drug for the same use or indication before the expiration of 7 years from the date

  24. Section 207.33 - What is the National Drug Code (NDC), how is it assigned, and what are its requirements?

    21 C.F.R. § 207.33   Cited 3 times   2 Legal Analyses

    (a)What is the NDC for a drug and what products must have unique NDCs ? The NDC for a drug is a numeric code. Each finished drug product or unfinished drug subject to the listing requirements of this part must have a unique NDC to identify its labeler, product, and package size and type. (b)What is the format of an NDC ? (1) Except as described in paragraph (b)(4) of this section, the NDC must consist of 10 or 11 digits, divided into three segments as follows: (i) The first segment of the NDC is