…Guidance on Regulatory Considerations for Human Cells, Tissues, and Cellular and Tissue Based Products: Minimal Manipulation and Homologous Use, together with the 36 months of enforcement discretion (with 22 months…

…to Endo/Par’s allegations, compounding with vasopressin is not unsafe and there is a clinical need for the compounded product. Athenex argues that because answers to these issues are also “central”…

…that federal law may circumscribe, but does not outright bar, possible theories of recovery by respondent.  Moreover, because those theories are at present undeveloped, this case’s interlocutory posture makes it…

…valid evidence (e.g., clinical pharmacology/biomarkers, animal models, real-world evidence and other externally controlled comparisons [e.g., natural history studies]), not just evidence from adequate and well-controlled studies, which would be consistent…

…difficult for companies – especially smaller ones – to upgrade their operational systems in time for January 1 compliance. Others commented that HRSA itself is not ready – the agency…

…Board concludes that Exela is not seeking approval for the exclusivity-protected changes approved in the supplements. Valcyte’s 3-year exclusivity relates to the new pediatric uses approved in the supplements. Exela…

…of the guides. Kaplan is a physician engaged in the business of providing medical services in exchange for payment: a commercial actor in a commercial setting, using a commercial product. …

…week a Manual of Policies and Procedures on internal FDA responsibilities and procedures for developing a single, shared system REMS or a separate REMS (here). Given FDA’s statement that the…

…designates Class III devices as “restricted devices” in premarket application (“PMA”) approval orders.  21 U.S.C. § 360e(d)(1)(B)(ii).  Some Class III devices perform elective procedures that tend to be advertised to…

…a conceptual standpoint, that interpretation produces circumstances that fail to treat “similar cases in a similar manner.” [(Internal citations omitted)] Thus, ruled Judge Contreras, “FDA’s prior interpretation was arbitrary and…

…sometimes requiring several separate responses about different issues regarding the same product.  Responding to such serial petitions requires the use of substantial FDA resources, on a repeated basis, over a…

…alternatively, why it is inapplicable.” As a result, writes Judge Contreras, “[t]he parties’ limited reliance on case law is also a hindrance to the Court’s analysis of the retroactivity question….

…to have black mold-like material on it.” Finally, there were several alleged instances where equipment appeared to be wet and where the residual moisture was not evaluated for microbial contamination….

…nonfunctional constituents by [FDA] or the United States Pharmacopeia for oral nonprescription drugs.” FDA would also be required to establish within the Center for Food Safety and Applied Nutrition a…

…clinical investigation of its medical device. Of course, under the “Responsible Corporate Officer” Doctrine, the government also can bring misdemeanor charges against company executives in FDA-regulated industries even when there…