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    • COVID-19—3d Cir.: Hospital’s vaccination mandate was internal policy which did not transform it into a state actor
    • ADMINISTRATION OF FDC ACT—FINAL RULES: Withdrawal of approval of new animal drug application
    • ADMINISTRATON OF FDC ACT—NOTICES: Determination that revia (naltrexone hydrochloride) tablets, 50mg, was not withdrawn from sale for reasons of safety, effectiveness
    • ADVERTISING (FOOD, DRUG & MEDICAL DEVICES)—S.D. Cal : Court dismisses false advertising action involving allegedly mislabelled “healthy” snack bars.
    • DRUGS AND BIOLOGICS—3d Cir.: Biologics manufacturers failed to establish irreparable harm in biosimilar controversy
    • EXPERT INSIGHTS—FDA Turns Up The Heat on GLP 1 Dupes Sold “For Research Use Only,” Finds Intended Use Suggests Otherwise
    • FALSE CLAIMS ACT—D. Mass.: DOJ files complaint alleging Illinois doctor was engaged in a Medicare fraudulent billing scheme
    • FOOD—M.D. Fla.: Florida federal court dismisses baby food contamination suit as shotgun pleading
    • FRAUD AND ABUSE—SETTLEMENT AGREEMENTS: ACA fraud claims resolved in $135M settlement
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    • MEDICAL DEVICES—FINAL RULES: Classification of the transcutaneous electrical nerve stimulator for the relief of congestion
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    Health Law Daily Wrap Up, ADMINISTRATION OF FDC ACT—FINAL RULES: Withdrawal of approval of new animal drug application, (Apr 17, 2026)

    By WK Editorial Staff

    Although deemed a rule under the FDC Act, the document does not meet the definition of “rule” in 5 U.S.C. 804(3)(A) because it is a “rule of particular applicability” and is not subject to the congressional review requirem ...

    By WK Editorial Staff

    Although deemed a rule under the FDC Act, the document does not meet the definition of “rule” in 5 U.S.C. 804(3)(A) because it is a “rule of particular applicability” and is not subject to the congressional review requirements in 5 U.S.C. 801—808.

    The FDA is amending the animal drug regulations to reflect application-related actions for new animal drug applications (NADAs), abbreviated new animal drug applications (ANADAs), and conditionally approved new animal drug applications (CNADAs) during October, November, and December 2025. The animal drug regulations are also being amended to improve their accuracy and readability. The final rule is issued under section 512(i) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 360b(i)). The rule is not subject to Executive Order 12866 (Final Rule, 91 Fed. Reg. 20337 (Apr. 16, 2026)).

    Dates. This rule is effective April 16, 2026.

    FederalRegisterIssuances: FinalRules FDCActNews DrugBiologicNews

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