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Lannett Company, Inc. et al v. United States Food And Drug Administration et al

MOTION for Summary Judgment and Memorandum in Support of Motion for Summary Judgment

95 Cited authorities

  1. Univ. of Tex. Sw. Med. Ctr. v. Nassar

    570 U.S. 338 (2013)   Cited 5,219 times   78 Legal Analyses
    Holding that application of the " ‘because’ of" requirement of Title VII's antiretaliation provision requires proof of "but-for" causation

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

    467 U.S. 837 (1984)   Cited 16,024 times   504 Legal Analyses
    Holding that courts "must give effect to the unambiguously expressed intent of Congress"

  3. Mathews v. Eldridge

    424 U.S. 319 (1976)   Cited 15,760 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"

  4. Board of Regents v. Roth

    408 U.S. 564 (1972)   Cited 14,686 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."

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

    463 U.S. 29 (1983)   Cited 6,636 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. Olim v. Wakinekona

    461 U.S. 238 (1983)   Cited 4,743 times
    Holding that the discretionary nature of the prison decision at issue negated any state-created liberty interest in the prison regulations that required a particular kind of hearing before the decision could be made

  7. Hardt v. Reliance Standard Life Ins. Co.

    560 U.S. 242 (2010)   Cited 1,328 times   30 Legal Analyses
    Holding a party need not "prevail[]" to obtain a fee award under § 1132(g); instead, a court has discretion to grant such an award as long as the party "has achieved some degree of success on the merits"

  8. Riegel v. Medtronic, Inc.

    552 U.S. 312 (2008)   Cited 1,031 times   62 Legal Analyses
    Holding that a State’s “‘requirements’” “includ[e] [the state’s] common-law duties”

  9. Leocal v. Ashcroft

    543 U.S. 1 (2004)   Cited 1,153 times   23 Legal Analyses
    Holding that a "DUI causing serious bodily injury" is not a "crime of violence"

  10. Sosa v. Alvarez-Machain

    542 U.S. 692 (2004)   Cited 1,168 times   16 Legal Analyses
    Holding that no "private cause of action" had been Congressionally authorized, and thus, plaintiff was "not entitled to a remedy"

  11. Section 1331 - Federal question

    28 U.S.C. § 1331   Cited 97,534 times   135 Legal Analyses
    Finding that in order to invoke federal question jurisdiction, a plaintiff's claims must arise "under the Constitution, laws, or treaties of the United States."

  12. Section 706 - Scope of review

    5 U.S.C. § 706   Cited 20,453 times   184 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 2,246 times   338 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 321 - Definitions; generally

    21 U.S.C. § 321   Cited 1,167 times   165 Legal Analyses
    Defining “new drug”

  15. Section 556 - Hearings; presiding employees; powers and duties; burden of proof; evidence; record as basis of decision

    5 U.S.C. § 556   Cited 902 times   14 Legal Analyses
    Permitting agency decision based "on official notice of a material fact not appearing in the evidence in the record" provided that party is afforded, "on timely request, . . . an opportunity to show the contrary"

  16. Section 360c - Classification of devices intended for human use

    21 U.S.C. § 360c   Cited 787 times   22 Legal Analyses
    Instructing FDA to determine the safety and effectiveness of a "device" in part by weighing " any probable benefit to health . . . against any probable risk of injury or illness . . ."

  17. Section 333 - Penalties

    21 U.S.C. § 333   Cited 436 times   39 Legal Analyses
    Defining civil and criminal penalties for violations of Section 331

  18. Section 334 - Seizure

    21 U.S.C. § 334   Cited 374 times   5 Legal Analyses
    Authorizing a libel for condemnation of adulterated and misbranded pharmaceuticals

  19. Section 351 - Adulterated drugs and devices

    21 U.S.C. § 351   Cited 340 times   32 Legal Analyses
    Referencing the U.S. Pharmacopeia's strength, quality, and purity standards

  20. Section 332 - Injunction proceedings

    21 U.S.C. § 332   Cited 268 times   6 Legal Analyses
    Granting the district court jurisdiction to restrain violations of FDCA

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

    21 C.F.R. § 314.70   Cited 353 times   38 Legal Analyses
    Defining "major changes" as those "requiring supplement submission and approval prior to distribution of the product"

  22. Section 314.150 - Withdrawal of approval of an application or abbreviated application

    21 C.F.R. § 314.150   Cited 87 times   4 Legal Analyses
    Requiring products to be withdrawn from the market where the FDA revokes approval

  23. Section 7.45 - Food and Drug Administration-requested recall

    21 C.F.R. § 7.45   Cited 3 times   1 Legal Analyses
    Providing authority to request recall

  24. Section 314.72 - Change in ownership of an application

    21 C.F.R. § 314.72   Cited 1 times

    (a) An applicant may transfer ownership of its application. At the time of transfer the new and former owners are required to submit information to the Food and Drug Administration as follows: (1) The former owner shall submit a letter or other document that states that all rights to the application have been transferred to the new owner. (2) The new owner shall submit an application form signed by the new owner and a letter or other document containing the following: (i) The new owner's commitment

  25. Section 12.1 - Scope

    21 C.F.R. § 12.1   Cited 1 times

    The procedures in this part apply when- (a) A person has a right to an opportunity for a hearing under the laws specified in § 10.50 ; or (b) The Commissioner concludes that it is in the public interest to hold a formal evidentiary public hearing on any matter before FDA. 21 C.F.R. §12.1

  26. Section 12.87 - Purpose; oral and written testimony; burden of proof

    21 C.F.R. § 12.87   Cited 1 times

    (a) The objective of a formal evidentiary hearing is the fair determination of relevant facts consistent with the right of all interested persons to participate and the public interest in promptly settling controversial matters affecting the public health and welfare. (b) Accordingly, the evidence at a hearing is to be developed to the maximum extent through written submissions, including written direct testimony, which may be in narrative or in question-and-answer form. (1) In a hearing, the issues

  27. Section 10.50 - Promulgation of regulations and orders after an opportunity for a formal evidentiary public hearing

    21 C.F.R. § 10.50   1 Legal Analyses

    (a) The Commissioner shall promulgate regulations and orders after an opportunity for a formal evidentiary public hearing under part 12 whenever all of the following apply: (1) The subject matter of the regulation or order is subject by statute to an opportunity for a formal evidentiary public hearing. (2) The person requesting the hearing has a right to an opportunity for a hearing and submits adequate justification for the hearing as required by §§ 12.20 through 12.22 and other applicable provisions

  28. Section 314.152 - Notice of withdrawal of approval of an application or abbreviated application for a new drug

    21 C.F.R. § 314.152

    If the Food and Drug Administration withdraws approval of an application or abbreviated application for a new drug, FDA will publish a notice in the FEDERAL REGISTER announcing the withdrawal of approval. If the application or abbreviated application was withdrawn for grounds described in § 314.150(a) or § 314.151 , the notice will announce the removal of the drug from the list of approved drugs published under section 505(j)(6) of the act and shall satisfy the requirement of § 314.162(b) . 21 C