…applies a different analysis, FTC Staff also concludes that for non-establishment disease efficacy claims, i.e., claims that a product treats, prevents or reduces the risk of diseases, only RCTs will…

…draft medical device appeals guidance with voluntarily adopted target deadlines for an appeal decision to be communicated within six weeks of submission of the written appeal or appeal meeting. A…

…Court was similarly unconvinced that alleged errors in the Identi ANDAs renedered FDA’s approval decisions arbitrary and capricious.  “[M]ost of these alleged errors are minor technical mistakes . . ….

…and essential facilities) are available and applicable here, argue Counterclaim Plaintiffs. As to Actelion’s argument that, for purposes of applicability of the essential facilities exception, companies can avail themselves of…

…Moreover, about 14 million people of all ages consume more than one-third of their daily calories in the form of added sugars. The Petition presents evidence to support its position…

…could be used for a clinical study as well as for specimen collection for a central repository.  Currently, compound authorizations are prohibited, which increases the burden on clinical trial sites…

…Finalization of the guidance document is intended to meet this FDASIA requirement.  An eCopy is required for nearly all medical device submissions, including  510(k)s, de novo petitions, PMAs, IDEs, HDEs,…

…Drugs;” however, there are several exemptions, including exemptions for “nonprescription drugs,” vitamins, supplements, herbal remedies, cosmetics, soap, detergent, “household cleaning products,” biological products for which the producer already provides a…

…withdraw the regulations establishing final monographs in the CFR. With that withdrawal, the administrative tasks associated with changing final monographs from regulations to final administrative orders will be complete and…

…[imported] samples or otherwise” that the product violates the FDC Act’s misbranding or new drug approval requirements, “then such article shall be refused admission” (emphasis added).   Although FDA contended that…

…to enable collection of FY 2013 GDUFA user fees without enactment of an appropriations act (see our previous post here).  GDUFA establishes several types of user fees that together will…

…would amend the definitions of “applicable device clinical trial” and “applicable drug clinical trial” at PHS Act § 402(j)(1)(A) to require that “all interventional biomedical studies on humans” be registered…

…the Special Controls put in place to mitigate false results, incorrect interpretation of results, and incorrect operation of the device. Design Verification and Validation Special Controls Analytical testing includes many…

…including data from research and clinical practice, that provides evidence that an alternate maximum day supply (other than the proposed 30-day supply). Additional safeguards or flexibilities that should be considered…