…if the revised regulatory impact statement adds anything to the earlier analyses. For one, the CBO estimates appears to have already considered some of the behavior changes that the final…

…contacted with preliminary or general questions, or to discuss whether an application-based mechanism or CPAM is more appropriate. Meetings with FDA: Traditional vs. CPAM Traditional application-based mechanisms include the pre-submission…

…approval of an alteration in a line of domestic pigs. The pigs are referred to as GalSafe because the alteration eliminates alpha-gal sugar (AGS) on the surface of their cells….

…walnuts may help lower cholesterol, protect against heart disease and stroke, and even fight depression and other mental illnesses.  Why the focus on food claims?  In her open letter to…

…medical devices; Innovative and essential pharmaceuticals; Digital health care; Advanced regenerative medicine and advanced bio-pharmaceuticals; DNA tests; Brain-machine interface; Infrastructure” We are excited to hear that South Korea is investing…

…sales access restriction plans, with FDA before the deadline. They also submitted long-term, controlled, and peer-reviewed studies to show that e-cigarettes generally cause smokers to switch to vaping. They also…

…critical safety information it had previously deemed essential.  After Mutual’s groundbreaking studies, FDA determined that information about dose adjustments and a low-dose colchicine regimen was mandatory for all single-ingredient oral…

…with history of highly symptomatic atrial fibrillation/flutter.  To the extent FDA Law Blog readers are aware of additional clinical superiority approval precedents, we’re all ears. Greater Effectiveness Clinical Superiority Determinations…

…clinical studies to be eligible for a voucher, and requiring the Comptroller General to conduct a review of the implementation and effectiveness of Risk Evaluation and Mitigation Strategies (“REMS”) (including…

…(Fiscal Year 2017), when OGD is expected to review and act on 90% of original ANDAs within 10 months from the date of submission, OGD anticipates that a typical 10-month…

…FDA approval – sometimes for more than a year – while the 5-year period of New Chemical Entity (“NCE”) exclusivity has ticked away.  By resetting the date of approval of…

…Preface is now significantly shorter, and merely states: “FDA’s regulations and guidance documents provide additional information regarding bioequivalence and bioavailability, including methodologies and statistical criteria used to establish the bioequivalence…

…to “increase device security and/or remediate vulnerabilities associated with controlled risk” and does not affect a software’s “essential clinical performance.”  Essential clinical performance is defined by the guidance as “performance…

By Alan M. Kirschenbaum – Just ahead of a predicted snow storm in the Baltimore-Washington area, CMS yesterday issued a blizzard of 658 pages constituting its final regulation implementing changes to…

…the term “drug” includes biological products but does not include medical devices. FDA does not provide information on the intent and driver for the proposed rule. The proposed rule creates…