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Amniotic Therapies, LLC v. U.S. Food and Drug Administration

Brief/Memorandum in Support

10 Cited authorities

  1. Canal Authority of State of Fla. v. Callaway

    489 F.2d 567 (5th Cir. 1974)   Cited 1,258 times
    Holding that the district court erred in shifting burden to the defendant because "[u]nder the proper view of the law, it should not have been incumbent upon the defendants to prove by a preponderance of the evidence, much less to a probable environmental and ecological certainty, that the interests they represent would suffer irreparable harm. The burden of persuasion on all of the four requirements for a preliminary injunction is at all times upon the plaintiff."

  2. Miss. Power Light v. United Gas Pipe Line

    760 F.2d 618 (5th Cir. 1985)   Cited 841 times
    Holding that a refund in the event of a rate overcharge would be an inadequate remedy, and the harm would thus be irreparable

  3. Clark v. Prichard

    812 F.2d 991 (5th Cir. 1987)   Cited 339 times
    Holding that the movant "must satisfy a cumulative burden of proving each of the four elements enumerated before a . . . preliminary injunction can be granted"

  4. Chacon v. Granata

    515 F.2d 922 (5th Cir. 1975)   Cited 86 times
    Concluding that irreparable harm requires a showing that: the harm to Plaintiff is imminent the injury would be irreparable and that Plaintiff has no other adequate legal remedy

  5. Section 706 - Scope of review

    5 U.S.C. § 706   Cited 20,964 times   230 Legal Analyses
    Granting courts jurisdiction to "compel agency action unlawfully held or unreasonably delayed"

  6. Section 551 - Definitions

    5 U.S.C. § 551   Cited 4,878 times   77 Legal Analyses
    Adopting the definition set out in the APA

  7. Section 264 - Regulations to control communicable diseases

    42 U.S.C. § 264   Cited 94 times   42 Legal Analyses
    Granting the FDA authority to "make and enforce such regulations as in [its] judgment are necessary to prevent the introduction, transmission, or spread of communicable diseases"

  8. Section 1271.440 - Orders of retention, recall, destruction, and cessation of manufacturing

    21 C.F.R. § 1271.440   Cited 1 times
    Allowing the agency to serve on an establishment an order to cease manufacturing until compliance with the regulations has been achieved

  9. Section 1271.21 - When do I register, submit an HCT/P list, and submit updates?

    21 C.F.R. § 1271.21

    (a) You must register and submit a list of every HCT/P that your establishment manufactures within 5 days after beginning operations or within 30 days of the effective date of this regulation, whichever is later. (b) You must update your establishment registration annually in December, except as required by § 1271.26 . You may accomplish your annual registration in conjunction with updating your HCT/P list under paragraph (c) of this section. (c) (i) If no change described in § 1271.25(c) has occurred

  10. Section 1271.400 - Inspections

    21 C.F.R. § 1271.400

    (a) If you are an establishment that manufactures HCT/Ps described in § 1271.10 , whether or not under contract, you must permit the Food and Drug Administration (FDA) to inspect any manufacturing location at any reasonable time and in a reasonable manner to determine compliance with applicable provisions of this part. The inspection will be conducted as necessary in the judgment of the FDA and may include your establishment, facilities, equipment, finished and unfinished materials, containers, processes