…and a “243% increase in the annual number of foreign device inspections” during the same time period. Report at 2. FDA also gives itself credit for implementing the Medical Device…

…McDonald’s Corporation, National Milk Producers Federation, National Pork Board, National Pork Producers Council, National Turkey Federation, Smithfield Foods, Inc., Tyson Foods, Walmart Inc., and Zoetis —announced the publication of a…

…approval. It’s therefore questionable whether this element will knock many petitions out of the 505(q) category. This guidance also further explains how FDA will determine that a petition was filed…

…individual testing recommendations, regarding non-clinical and clinical evaluation of OCT devices, and increased interactive engagement improve the process and reduces overall total time to decision. Requests for participation in the…

…goal of promoting “safe, effective, and high-quality medical devices” that are based on Artificial Intelligence/Machine Learning (AI/ML) technologies. Guiding Principle 10 focused on monitoring the performance of the models and…

…Congress enacted CLIA following reports of inaccurate Pap smear results intended to detect cervical cancer precisely to ensure the “accuracy and reliability of all laboratory testing.” Under this paradigm, only…

…(paragraph IV exclusivity) and the ANDA cannot be a drug for which other ANDA applicants were eligible for but forfeited paragraph IV exclusivity. Importantly, CGT exclusivity is triggered by the…

…purposes of determining whether a particular clinical trial is an “applicable drug clinical trial” under Title VIII of PL 110‐85 (section 402(j)(1)(A)(iii) of the PHS Act).  Although Phase 1 clinical…

…the original records”); and §§ 211.188, 211.194, and 212.60(g) (requiring “complete information,” “complete data derived from all tests,” “complete record of all data,” and “complete records of all tests performed”)….

…(“CSA”), qualified practitioners can prescribe, administer or dispense buprenorphine products for the treatment of opioid use disorder in an office, community hospital, health department or correctional facility. 21 U.S.C. §…

…allegedly been overwritten. They also concluded that they found multiple instances of trial injections of samples, where the final tests were recorded, but the original results had apparently not been….

…a legitimate medical purpose by an individual practitioner acting in the usual course of his professional practice. See, e.g., 21 C.F.R. § 1306.04(a). The same is true for action against…

…July 2012 is not unconstitutional.  The Court succinctly (and with a little snark) captures its decision in a concluding paragraph: The parties agree that the Alameda County Safe Drug Disposal…

…ruled that federal law does not preempt state-law design defect claims concerning generic drug products because any conflict between federal and state law can be avoided if the the generic…

…occur in FDA’s user fee programs. While Congress did allow for some exemptions from fiscal year limitations and for some amounts to be carried forward into subsequent fiscal years, it…