§Why CasetextPricing

Eagle Pharmaceuticals, Inc. v. Burwell et al

MOTION for Summary Judgment [REDACTED]

65 Cited authorities

  1. Chevron U.S.A. v. Natural Res. Def. Council

    467 U.S. 837 (1984)   Cited 16,035 times   504 Legal Analyses
    Holding that courts "must give effect to the unambiguously expressed intent of Congress"

  2. Mathews v. Eldridge

    424 U.S. 319 (1976)   Cited 15,793 times   42 Legal Analyses
    Holding that a procedure based on written submissions was adequate because it included safeguards against mistake including that the agency informed the recipient of its tentative assessment and the evidence supporting it and an opportunity was then afforded the recipient to submit additional evidence "enabling him to challenge directly the accuracy of information in his file as well as the correctness of the agency's tentative conclusions"

  3. Board of Regents v. Roth

    408 U.S. 564 (1972)   Cited 14,700 times   4 Legal Analyses
    Holding that where a public employee's appointment terminated on a particular date and there was no provision for renewal after that date, the employee "did not have a property interest sufficient to require . . . a hearing when [the officials] declined to renew his contract of employment."

  4. Cleveland Board of Education v. Loudermill

    470 U.S. 532 (1985)   Cited 6,904 times   7 Legal Analyses
    Holding that the tenured public employee was "entitled to oral or written notice of the charges against him, an explanation of the employer's evidence, and an opportunity to present his side of the story"

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

    463 U.S. 29 (1983)   Cited 6,645 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]'"

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

    529 U.S. 120 (2000)   Cited 1,510 times   40 Legal Analyses
    Holding that Congress had not yet empowered the FDA to regulate tobacco products

  7. Universal Camera Corp. v. Nat'l Labor Relations Bd.

    340 U.S. 474 (1951)   Cited 9,569 times   3 Legal Analyses
    Holding that court may not "displace the Board's choice between two fairly conflicting views, even though the court would justifiably have made a different choice had the matter been before it de novo "

  8. U.S. v. Johnson

    529 U.S. 53 (2000)   Cited 801 times
    Holding that courts may not use excess prison time served to offset the length of a supervised-release term

  9. Armstrong v. Manzo

    380 U.S. 545 (1965)   Cited 2,557 times   3 Legal Analyses
    Holding that failure to give proper notice violates "the rudimentary demands of due process of law"

  10. MCI Telecommunications Corp. v. American Telephone & Telegraph Co.

    512 U.S. 218 (1994)   Cited 387 times   4 Legal Analyses
    Holding Congress did not authorize "a fundamental revision" of the law through a "subtle device"

  11. Rule 56 - Summary Judgment

    Fed. R. Civ. P. 56   Cited 329,526 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 20,488 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 2,250 times   339 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 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

  15. Section 355-1 - Risk evaluation and mitigation strategies

    21 U.S.C. § 355-1   Cited 37 times   18 Legal Analyses
    Providing that the FDA will send a letter to health care providers on behalf of an ANDA holder if such letter is a necessary part of a risk evaluation and mitigation strategy

  16. Section 360bb - Designation of drugs for rare diseases or conditions

    21 U.S.C. § 360bb   Cited 19 times   11 Legal Analyses
    Directing that the FDA “shall by regulation promulgate procedures for the implementation of” the designation requirement

  17. Section 45C - Clinical testing expenses for certain drugs for rare diseases or conditions

    26 U.S.C. § 45C   Cited 6 times   4 Legal Analyses

    (a) General rule For purposes of section 38, the credit determined under this section for the taxable year is an amount equal to 25 percent of the qualified clinical testing expenses for the taxable year. (b) Qualified clinical testing expenses For purposes of this section- (1) Qualified clinical testing expenses (A) In general Except as otherwise provided in this paragraph, the term "qualified clinical testing expenses" means the amounts which are paid or incurred by the taxpayer during the taxable

  18. Section 379h - Authority to assess and use drug fees

    21 U.S.C. § 379h   Cited 4 times   5 Legal Analyses

    (a) Types of fees Beginning in fiscal year 2023, the Secretary shall assess and collect fees in accordance with this section as follows: (1) Human drug application fee (A) In general Each person that submits, on or after September 1, 1992, a human drug application shall be subject to a fee as follows: (i) A fee established under subsection (c)(6) for a human drug application for which clinical data (other than bioavailability or bioequivalence studies) with respect to safety or effectiveness are

  19. Section 314.110 - Complete response letter to the applicant

    21 C.F.R. § 314.110   Cited 30 times   6 Legal Analyses
    Describing FDA process for complete response letters

  20. Section 316.3 - Definitions

    21 C.F.R. § 316.3   Cited 12 times   16 Legal Analyses

    (a) The definitions and interpretations contained in section 201 of the act apply to those terms when used in this part. (b) The following definitions of terms apply to this part: (1)Act means the Federal Food, Drug, and Cosmetic Act as amended by section 2 of the Orphan Drug Act (sections 525-528 (21 U.S.C. 360aa - 360dd )). (2)Active moiety means the molecule or ion, excluding those appended portions of the molecule that cause the drug to be an ester, salt (including a salt with hydrogen or coordination

  21. Section 316.20 - Content and format of a request for orphan-drug designation

    21 C.F.R. § 316.20   Cited 4 times   6 Legal Analyses

    (a) A sponsor that submits a request for orphan-drug designation of a drug for a specified rare disease or condition shall submit each request in the form and containing the information required in paragraph (b) of this section. A sponsor may request orphan-drug designation of a previously unapproved drug, or of a new use for an already marketed drug. In addition, a sponsor of a drug that is otherwise the same drug as an already approved drug may seek and obtain orphan-drug designation for the subsequent

  22. 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

  23. Section 314.102 - Communications between FDA and applicants

    21 C.F.R. § 314.102   Cited 3 times
    Permitting applicants to correct application deficiencies by amendment during the review process

  24. Section 316.25 - Refusal to grant orphan-drug designation

    21 C.F.R. § 316.25   Cited 3 times   3 Legal Analyses

    (a) FDA will refuse to grant a request for orphan-drug designation if any of the following reasons apply: (1) The drug is not intended for a rare disease or condition because: (i) There is insufficient evidence to support the estimate that the drug is intended for treatment of a disease or condition in fewer than 200,000 people in the United States, or that the drug is intended for use in prevention or in diagnosis in fewer than 200,000 people annually in the United States; or (ii) Where the drug

  25. Section 316.34 - FDA recognition of exclusive approval

    21 C.F.R. § 316.34   Cited 2 times   3 Legal Analyses

    (a) FDA will send the sponsor (or, the permanent-resident agent, if applicable) timely written notice recognizing exclusive approval once the marketing application for a designated orphan-drug product has been approved, if the same drug has not already been approved for the same use or indication. The written notice will inform the sponsor of the requirements for maintaining orphan-drug exclusive approval for the full 7-year term of exclusive approval. (b) When a marketing application is approved

  26. Section 316.24 - Deficiency letters and granting orphan-drug designation

    21 C.F.R. § 316.24   Cited 1 times   3 Legal Analyses

    (a) FDA will send a deficiency letter to the sponsor if the request for orphan-drug designation lacks information required under §§ 316.20 and 316.21 , or contains inaccurate or incomplete information. FDA may consider a designation request voluntarily withdrawn if the sponsor fails to respond to the deficiency letter within 1 year of issuance of the deficiency letter, unless within that same timeframe the sponsor requests in writing an extension of time to respond. This request must include the