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…comments will be accepted until February 6, 2023. As a brief reminder, the July 9, 2021 Executive Order directed FDA to write a letter to the USPTO describing concerns about…
…civil complaint against GoodRx for data privacy breaches. The case includes a proposed order that may sharply narrow the company’s ability to traffic in consumer data, often a key part…
…consider three of the eight factors in 21 U.S.C. § 811(c). The DEA set forth its findings with respect to the following factors 4, 5, and 6: (4) history and…
…how much preclinical and preliminary clinical evidence is available and how compelling it is. FDA also encourages sponsors to use an independent data monitoring committee (“DMC”) and take into consideration…
…is validated, the test report includes certain required disclaimers, and the company has submitted a notification to FDA. The combined effect of these and other steps has been to increase…
…Injectable Suspension, for Intramuscular Injection 300 mg/vial and 400 mg/vial, approved under NDA 202971. ARISTADA is a prodrug of N-hydroxymethyl aripiprazole (and which N-hydroxymethyl aripiprazole is a prodrug of aripiprazole)…
…agency action, and therefore not subject to court review. “‘The compliance order is not ‘final agency action.’ See 5 U.S.C. 704. A[n] . . . order marks only a step in…
…can only qualify for the exemptions if all of the facility’s compounded drugs are compounded in accordance with Section 503B. If a compounder does not intend to compound all drugs…
…testosterone will be regulated. Importantly, the Attorney General will be authorized to issue an order adding a substance to the definition of “anabolic steroid” upon finding that: (1) the substance…
…issues a warning letter citing a company for a late eMDR under this system. Even more interesting will be the first company that responds to such a warning letter explaining…
…stymied the company’s efforts to “restore” orphan drug exclusivity for the pre-term birth drug MAKENA (hydroxyprogesterone caproate) Injection, 250 mg/mL, the compounded version of which is known as “17P.” In…
…are met. This means that order counts, and that to obtain NCE exclusivity for a combination drug containing new and old actives, the NCE component must be approved first, followed…
…February 29, 2012 when DEA extended temporary scheduling until August 29, 2012. DEA explained in the March 1, 2011 Final Order that a cannabinoid “is a class of chemical compounds…
By Kurt R. Karst – The long-running dispute over a Patent Term Extension (“PTE”) for U.S. Patent No. 5,196,404 (“the ‘404 patent”) covering The Medicines Company’s (“MDCO’s”) ANGIOMAX (bivalirudin) may…
…arguments from the Intervenor Appellants, which are two companies with generic versions of Eagle’s drug currently being excluded from the market. The intervenors argued that the district court’s decision should…