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…triggering purposes. Several years later, in Teva Pharm., USA, Inc. v. FDA, 398 F. Supp. 2d 176 (D.D.C. 2005), Teva challenged an FDA decision that a dismissal of a declaratory…
…provision: the effective date of the final approval of Teva Pharmaceuticals USA, Inc.’s Abbreviated New Drug Application No. 77-342 shall be no earlier than the date of the expiration of…
…processes for submission of electronic MDRs (eMDRs) to FDA, in accordance with the Medical Device Reporting: Electronic Submissions Requirements Final Rule (eMDR Final Rule) published in the Federal Register of…
…by potential generic competitors, but the FDA mayor may not decide to give final approval to competing generics and it mayor may not decide to give final approval in a…
…Applications and 505(b)(2) Applications—Final Rule (the “MMA Final Rule”), 81 Fed Reg. 69580, 69609 (Oct. 6, 2016) (adopting proposed rule that applicants must “satisfy the notice requirement of the [Hatch-Waxman]…
…product does not infringe the ‘602 patent. But can an applicant seek a declaratory judgment against a disclaimed patent? What is the actual and justiciable controversy? Citing the recent Federal…
…30-month stay of ANDA approval. So, what’s the deal?? After all, the statute and FDA’s regulations state that a patent is considered timely listed if information is submitted to FDA…
…compete. A declaratory judgment redresses this alleged injury because it eliminates the potential for the corresponding listed patent to exclude the generic drug from the market.” (Internal citations omitted.) Given…
…until 2008 that the statute was amended to authorize the Consumer Product Safety Commission (“CPSC”) to impose criminal liability against individual directors, officers, or agents of a corporation for violating…
…FDA asserts in the Warning Letter that drugs produced at the Homeolab USA facility are deemed adulterated because of the company’s refusal to allow photographs. Also, because Homeolab USA’s parent…
…that, as a result of the D.C. Circuit’s March 2, 2010 decision in Teva Pharms USA, Inc. v. Sebelius, Teva did not forfeit 180-day exclusivity eligibility. (For additional background on…
…of the historical background that spurred Congressional action here, including national security risks highlighted by U.S. Departments of Defense (DoD) and Commerce actions against several specific Chinese biotechnology companies. An…
…drug patent settlement agreements (here), user fees (here), orphan drugs (here), or just general FDA regulation (here). We find it all rather interesting. After all, data can provide an informative…
…dramatic effect on import alerts. FDA issued 28 quality-related import alerts in 2022, and most of those 28 alerts were for hand sanitizers that contained impurities or had other defects….
…minimal safety standard, but did in fact “establish both ‘floor’ and ‘ceiling’.” Although it might be said that this preamble was a politically motivated legal opinion about statutory construction and…