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…necessary health care items and services. However, the OIG solicits comments on whether this phrase should be interpreted more broadly to include encouraging, supporting, or helping patients to access care,…
…to FDA, the company must first conduct studies comparing its proposed product to the brand-name reference product. In order to do so, the generic drug manufacturer must first obtain reference…
…Capsules as an orphan drug for the treatment of nephropathic cystinosis in adults and children age 6 years and older. FDA approved the drug, from Raptor Therapeutics, Inc. (“Raptor”), on…
…(“Gilead”), the sponsor of NDA 203100 for STRIBILD (elvitegravir, cobicistat, emtricitabine, tenofovir disoproxil fumarate) Tablets (approved on August 27, 2012), submitted a Citizen Petition (Docket No. FDA-2016-P-3312) to FDA in…
…quality metrics program from the four proposed metrics in the July 2015 Draft Guidance (i.e., lot acceptance rate, product quality complaint rate, invalidated out-of-specification rate, and product quality review on…
…Rannazzisi, Deputy Administrator, Office of Diversion Control, Drug Enforcement Administration, Before the Subcommittee on Oversight and Investigations Committee on Energy and Commerce, U.S. House of Representatives, “Examining the Growing Problems…
On July 11, 2017, the Department of Justice and the Drug Enforcement Administration (“DEA”) announced that Mallinckrodt LLC, a pharmaceutical manufacturer, agreed to pay $35 million to settle allegations related…
…Confirms Compliance Re-Org, DEVICES & DIAGNOSTICS LETTER (FDA News, Falls Church, V.A.), Sept. 30, 2013, at 1. If 60% of new Pre-Subs are refused under the Pre-Sub Guidance’s Acceptance Review,…
…510(k)s were refused under the RTA. CDRH Meeting FDASIA Goals, Confirms Compliance Re-Org, DEVICES & DIAGNOSTICS LETTER (FDA News, Falls Church, V.A.), Sept. 30, 2013, at 1. According to Dr….
…supplement the diet by increasing the total dietary intake, or (F) a concentrate, metabolite, constituent, extract, or combination of any ingredient described in clause (A), (B), (C), (D), or (E).”…
…replace, without charge, products purchased by physicians, clinics, and hospitals if the products became spoiled or otherwise unusable after purchase. Under the program, products could only qualify for replacement if…
…a Writ of Mandamus order to compel discovery. The Federal Circuit denied both of these requests as meritless. Disposing of the Motion to Compel Discovery quickly, the Federal Circuit explained…
…20, 2013,” and, among other things, an order directing FDA “to recognize that UTC is entitled to all benefits of orphan drug exclusivity approval,” and “[i]njunctive relief effectuating UTC’s orphan…
…derivatives) bound to an identical sugar backbone (ribose, deoxyribose, or modifications of these sugars), unless the subsequent drug were shown to be clinically superior. (D) Closely related, complex partly definable…
As we previously reported, FDA recently extended the compliance date for its restaurant menu labeling regulations to May 8, 2018. Just one day before the previous (May 5, 2017) compliance…