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…Order granting the government’s motion for an Order to Show Cause. We will post a more detailed analysis of the Bayer case and its potential effects in the coming days. …
…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 …
…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,…
…to R product. The proposed generic product need not have the same formulation design as the R product. In order to adequately compare R and T products, a potential ANDA…
…suspicious order reporting and monitoring. DEA stated that, short of providing arbitrary thresholds to distributors, “it cannot provide more specific suspicious orders guidance because the variables that indicate a suspicious…
…Register. Id. at 50,041 codified at 21 C.F.R. § 1308.50(b). DEA must also transmit the notice of a proposed order to HHS and take into consideration comments from that agency….
…compounded and commercially available substances are “identical,” and, if compounded from bulk substances, whether the compounded version produces a “clinical” difference for the patient (which FDA generally describes the same…
…a number of UK drug facilities from EU oversight over the coming years. In a recent interview, Ms. Corrigan said that $18.5 million in inspection costs could be used elsewhere…
…regulations. FDA has stated that comments to the draft guidance should be submitted by October 11, 2016 in order to ensure that the Agency considers them before it begins work…
…relying for the conclusion that such software should be regulated. The notice must allow for at least 30 days of public comment before issuing a final order or withdrawing the…
…Order which shall commence on the date this Order is mailed. Pilgram, 82 Fed. Reg. at 11,059 n.4. While this practice still does not clear up other concerns with DEA…
…days (meaning, since President Trump’s inauguration, not coincidentally). Now comes across our computer screen a district court denial of a motion to dismiss filed by a defendant indicted for illegally…
…method for making cGMP comparisons between facilities manufacturing similar products, or for comparing the results from within a facility over multiple inspections. (This author will acknowledge that the agency has…
…for PREPOPIK, he reversed course after considering several precedents identified by Ferring in the company’s Motion for Reconsideration, and submitted in response to comments mande by Judge Contreras in his…
…between FDA and Senators Hatch and Harkin, Commissioner Hamburg committed to issuing a revised draft in order to address the concerns of Congress and industry. Four years later, in August…