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…Clinical usability or human factor studies may also be required, depending on the indication and the patient population, the nature of the auto-injector design, and differences from the auto-injector constituent…
…auto-injector constituent part, [the Agency] must evaluate the auto-injector constituent part of the combination product for which ANDA approval is sought to ensure that its performance characteristics and critical design…
…that voluntary “Made in USA” labeling for beef products, without a clear definition of what constitutes “Made in USA” or “Product of USA” or other such similar designations, will lead…
On July 1, 2021, the Federal Trade Commission (FTC) announced the availability of the pre-publication of the final rule on “Made in USA” (MUSA) claims in the Federal Register. The…
…gained in popularity. TINA.org alleges that many products marketed with unqualified Made in the USA claims violate the standard set by FTC, i.e., all or virtually all components must be…
…from including unqualified Made in USA claims on product labels unless: final assembly or processing of the product occurs in the United States; all significant processing that goes into the…
…of USA claim to beef from animals born, raised, and slaughtered in the USA. However, based on concerns expressed that such policy change could potentially affect the integrated livestock supply…
…expanded vaccine that treats all of the bacterial strains covered by the original vaccine plus additional ones. Like the original, the expanded vaccine is the only FDA-approved pneumococcal conjugate vaccine…
…10. 21 CFR 870.5200 External cardiac compressor. 11. 21 CFR 870.5225 External counter-pulsating device. 12. 21 CFR 870.5310 Automated external defibrillator. 13. 21 CFR 872.3640(b)(2) Endosseous dental implant (blade form)….
…Petitioners claim that the current labeling policy “can lead to the disguising of the true origin of the meat and meat products and allows foreign interests and multi-national corporations to…
…its ANDA. The Complaint also alleges that FDA’s decision, which blocks Mylan and other generic entrants from launching their generic Provigil products, is unlawful. Mylan believes the Federal Trade Commission…
…(bb) an approved method of using the drug. The MMA also added almost identical counterclaim provisions at FDC Act §505(j)(5)(C)(ii)(I) applicable to ANDA sponsors. Both counterclaim provisions refer to FDC…
…yet been approved), follows almost identical Advisory Opinion Requests filed in January 2005 by GlaxoSmithKline (Docket No. 2005A-0015), in August 2006 by AstraZeneca (Docket No. 2006A-0318), and in June 2007…
…on the final list. FDA’s notification also, separately and somewhat unrelated to the proposed list, clarifies its policy regarding orthopedic manual surgical instruments that are appropriately classified as Class I…
…exclusive approval, as appropriate, for those additional subsets from the date of such additional marketing approval(s). Before obtaining such additional marketing approval(s), the sponsor in this instance would not need…