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…of its inspection budget. According to Howard Sklamberg, FDA’s Deputy Commissioner for Global Regulatory Operations and Policy, “…we cannot be the inspectors for the world. Hence, we need to effectively…
…commerce. This was followed by the afore-mentioned plea agreement, under which Mr. Feijo will plead guilty to one count of willful failure to collect, account for or pay a tax,…
…to Show Cause, Bayer’s response to that motion, the Council for Responsible Nutrition’s and Natural Products Association’s requests to participate as amici, and the Court’s Order granting the government’s motion…
…whether they complied with human subject protection guidelines; a “full statement of all components, ingredients, additives, and properties, and of the principle or principles of operation” of the product; and …
…§ 351(l)(2), is not mandatory.) In Sandoz, however, Sandoz did not partake in the patent dance. Apotex decided otherwise and engaged Amgen in the dance. Apotex, like Sandoz before it,…
…may be distributed by a company without violating the misbranding provisions of the FDC Act. See, e.g., United States v. Caronia, 703 F.3d 149 (2d Cir. 2012); Op. and Order,…
…health system to hospitals, clinics, infusion pharmacies, long term care facilities. Sometimes, hospitals compound after receipt of a prescription, but they also compound before receipt of a prescription, and hold…
…previous posts here, here, here, and here; and comment here). A brief recap: In the 1980s FDA attempted to keep dietary supplements, other than traditional vitamins and minerals, off the…
…our previous post here), FDA proposes “to require a 505(b)(2) applicant to identify a pharmaceutically equivalent product, if already approved, as a listed drug relied upon, and comply with applicable…
…and Education Act (“DSHEA”), which amended the Federal Food, Drug, and Cosmetic Act (“FD&C Act”). The 2011 draft elicited a host of comments (including two from us, here and here)…
…information, appointment schedules, business analytics, information about patient populations, admissions, practice and inventory management, analysis of historical claims data to predict future utilization or cost-effectiveness, determination of health benefit eligibility,…
…violates the Administrative Procedure Act’s (APA) minimal notice requirements and deprives aggrieved parties of due process. We note that in a final order published last Friday, Paul E. Pilgram, M.D.,…
…selling herbal supplements, which, it is alleged, are illegal misbranded drugs. Judge Danny Reeves of the federal district court in Lexington, Kentucky, issued a very brief order, but some of…
…15, 2022. Human blood, human plasma, [and] human tissues are not included within the scope of the Amended Sectoral Annex.” As some of our readers may recall, we blogged about…
…because of the order in which it was approved, those circumstances might render the FDA’s policy arbitrary and capricious.” In addition to PREPOPIK, Ferring identified STRIBILD (elvitegravir, cobicistat, emtricitabine, tenofovir…