…2012 enactment of the Food and Drug [Administration] Safety and Innovation Act (FDASIA). Surveys conducted by the American Association of Nurse Anesthetists, the American Hospital Association, and the American Society of…

…and a detailed plan for the allocation of the remaining funds. Specifically, the Committee requests that FDA identify and report to the Committee an itemized accounting of any and all…

…. . the application [for clearance or approval] and to generate a written evaluation. FDA then integrates the conclusions from these separate review activities to determine the appropriate outcome for…

…Limited population pathway. Section 3042 amends the FDC Act to allow FDA to approve an antibacterial or antifungal drug, along or in combination with other drugs, as a limited population…

…and entered into a separate SPA with FDA (the “ANCHOR SPA”). In connection with the ANCHOR SPA, Amarin also agreed to conduct a cardiovascular outcomes trial (the REDUCE-IT trial) to…

…to the “conditions of approval [of an] original application” (emphasis added) and prevents FDA from approving a 505(b)(2) application (or an ANDA) for a drug for those new conditions for…

…a listed drug on the “date of approval” of the NDA or ANDA (see section V.A.3). Revises the definition of “substantially complete application”- to describe an ANDA that on its…

…submit any documentation to its ANDA of providing such notice,” and that “[a]t least one other applicant submitted a substantially complete ANDA (or an amendment to a substantially complete ANDA)…

…of a supplemental application if (a) there are existing data available and acceptable to FDA to demonstrate safety of the drug and (b) all data used to develop the qualified…

…they had appropriate analytical and clinical test validation data on file and submitted a “notification” to FDA of their intent to distribute. FDA, Guidance for Clinical Laboratories, Commercial Manufacturers, and…

…are affiliated with the applicant and the number of employees for the applicant and its affiliates.  SBA will send the applicant a request for information, and SBA will make a…

…a manufacturer’s ability to identify an adequate predicate device and provide accurate and up-to-date information on the intended use and technological characteristics of predicates.  All of these reforms are much…

…also require these companies to share with these same competitors the use and distribution arrangements they developed to manage the risks of the products. Supporters describe the bill as the…

…by Amarin, the court also addressed Amarin’s general request for First Amendment protection for truthful and non-misleading off-label promotion. The court heavily relied on the precedent-setting analysis in Caronia, although…

…a drug, a phase-in formula is applied to obtain the final MFN Drug Payment Amount during the first four years of the model. The phase-in formula for year one (2021)…