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…deviates from devices generally available or from an applicable performance standard or premarket approval requirement in order to comply with the order of an individual physician or dentist; (2) Is…
… RELATED READING: April 5, 2007 Orange Book Blog Post UPDATE: Earlier today, the U.S. District Court for the District of Columbia issued an order extending from April 11, 2007…
…order, which addressed the merits of MDCO’s underlying claims and found in MDCO’s favor (the ‘merits appeal’).” APP responded that the company does have standing and that MDCO’s request to…
…here). And about a year after NDA approval, FDA ordered companies marketing unapproved single-ingredient oral colchicine to remove their products from the market. Companies that wanted to market generic or…
…companies provided patients with access to FDA-approved birth control. In October 2022, the Committee issued a report titled “Barriers to Birth Control: An Analysis of Contraceptive coverage and Costs for…
…seeking an order to immediately stop defendants from handling and dispensing controls. The District Court denied the Government’s motion for a preliminary injunction because it failed to comply with the…
…(Apr. 30, 2019), which became the second company of only three companies to date ever to receive such an order. Accordingly, the CTP’s 122-page “Decision Summary” for IQOS, U.S. Food…
…the Hatch-Waxman Amendments—protecting intellectual property while also facilitating generic drug access—and has potentially massive implications for the generic industry. Compliance and Enforcement Anne Walsh, John Fleder, and Robert Dormer provide…
…suspended the inspection requirement to renew Class A-S (community pharmacy engaged in sterile compounding), Class B (nuclear pharmacies), Class C-S (hospital, ambulatory surgery center, or institutional pharmacy engaged sterile compounding),…
…commercial use of the drug. The difficulty of obtaining FDA approval for multiple NDAs for the same drug on the same first day making a company eligible for multiple PTEs…
…an order using a Form 222, and approximately 3 minutes to complete an order for CIIs using CSOS. 5. Impact on Long-Term Care Facilities (“LTCFs”) Although several comments addressed the…
…v. FDA, 733 F.3d 1 (D.C. Cir. 2013 (“Beaty/Cook”). Fast-forward to FDA’s April 2017 decision, in which the Agency concludes: FDA is bound by the terms of the order issued…
…the company’s Vancocin drug off the market. The FTC sued Shire in the U.S. District Court for the District of Delaware in 2017, alleging that the company’s actions were anticompetitive…
…in FTC v. AMG Capital Mgmt., LLC. There, the court ruled in favor of the FTC’s pursuit of equitable remedies: The court conceded that defendant’s argument regarding the FTC’s lack…
…Commerce Clause by regulating interstate commerce. Compl. at 3. Second, PhRMA alleged that SB 17 violates the First Amendment by compelling manufacturers to speak and in a manner that expresses…