…drug company’s commitment, as part of a settlement agreement, not to launch an Authorized Generic (“AG”) to compete with a generic version of the product approved under an ANDA –…

…on device-led combination products seeking breakthrough designation, noting that such devices might present complex issues requiring expertise from a different Center and may, therefore, require additional time to resolve. The…

…“181 days after” after first-filer marketing); Caraco Pharm. Labs., Ltd. v. Forest Labs., Ltd., 527 F.3d 1278, 1284 (Fed. Cir. 2008) (same); Altana PharmaAG v. Teva Pharms. USA Inc., no….

…per year.  We find it interesting that FDA states it will provide these updates on its website, but it does not indicate how it will communicate the initial notice.  It…

…filer; and (5) 75 days after the challenged patent is delisted. No forfeiture occurs, however, unless one of dates (1)-(2) and one of dates (3)-(5) have come to pass. ….

…to an electronic database, and now to an app (see our previous post here). Although the Orange Book has become more complex to navigate, the first edition was rather simple,…

…25, 2016 FDA Peripheral and Central Nervous System Advisory Committee meeting – this first known presentation by a patient advocate during the core presentation at an FDA advisory committee meeting…

…developed for use by the general population for a fee or at no cost, and can be easily accessed via a desktop computer, a smartphone, or an iPad. These health…

…Century Cures Initiative, which was launched in April 2014 by now-Chairman of the House Energy and Commerce Committee Representative Fred Upton (R-MI) and Committee Member Representative Diana DeGette (D-CO).  That…

…requirement that manufacturers help facilitate importation or risk criminal liability. For example, the Final Rule requires manufacturers to either test SIP-imported products for free or turn over trade secrets and…

…of its investment-backed patent rights and common-law right to sell its products at market prices free from governmental constraints. AstraZeneca also claimed that CMS’s revised guidance on the Negotiation Program…

…post recommendations for BE studies in draft form at http://www.fda.gov/cder/guidance/bioequivalence/default.htm, and seek public comment.  Users will also be able to search the web site for recommendations on specific drug products. …

…online communications are manufacturers, packers, or distributors accountable?  More specifically:  What criteria should be applied to determine when third-party communications are subject to substantive influence by companies that market products…

…that, “the trial participant still provides consent and the statement is required during the oral presentation of the research and/or in the written statement regarding the research, if required by…

FDA recently launch a redesigned website that is aimed at improving the “look and feel” of all FDA websites.  According to the Agency: The new site organization is intended to…