…the application. Such an understanding is critical to addressing the review division’s findings through additional data or analyses, and is even more essential should the company choose to appeal those…

…purposes) comprising: All individuals and entities in the United States and its territories who, for purposes other than resale, purchased, reimbursed, and/or paid for Neurontin for indications not approved by…

…minimal safety standard, but did in fact “establish both ‘floor’ and ‘ceiling’.”  Although it might be said that this preamble was a politically motivated legal opinion about statutory construction and…

…federal contract. To state the inverse, the Act does not apply in cases where federal contractors do not use “biotechnology equipment or services” acquired from a “biotechnology company of concern”…

…Report helps emphasize the global challenges FDA faces trying to ensure quality. After the U.S., the most prominent site for facilities was India, with over 600 sites. China was third…

…drug patent settlement agreements (here), user fees (here), orphan drugs (here), or just general FDA regulation (here).  We find it all rather interesting.  After all, data can provide an informative…

…these agencies gather data and information and may even seek public comment. Importantly, agencies deliberate internally and (often) with other governmental agencies. There is no doubt that the contents of…

…for reconsideration of patent term extension applications to a single submission within the times specified in the rule.”  TMC had already requested reconsideration of the PTO’s denial of a PTE…

…what FDA terms the “First Effective Approach” in the Agency’s SUBOXONE Letter Decision, which is the approach affirmed in cases such as Purepac Pharmaceutical Co. v. Thompson, 354 F.3d 877…

…the Patent and Trademark Office’s (“PTO’s”) denial of a Patent Term Extension (“PTE”) for U.S. Patent No. 5,196,404 (“the ‘404 patent”) covering The Medicines Company’s (“MDCO’s”) ANGIOMAX (bivalirudin), and remanded…

…complexities of regulatory and compliance challenges within the marketing and promotion of pharmaceuticals, biologics, and medical devices in an evolving environment. Featured topics include: FDA updates on recent enforcement actions…

…practical real-world examples that will help you to excel in your everyday practices. Join the “Who’s Who” of the FDA Bar and don’t miss your opportunity to join their ranks!…

…transluminal coronary angioplasty.  The ‘404 patent expires on March 23, 2010, but is subject to a 6-month period of pediatric exclusivity that FDA granted in June 2009 after the Medicines…

…Deferred Prosecution Agreements DISSEMINATE peer-reviewed studies of off-label uses and AVOID off-label scrutiny AVOID anti-kickback red flags when handling activities involving prescribers and purchasers DESIGN compliant policies and procedures for…

…date after product approval.  AstraZeneca cites several examples of PTEs allegedly granted since 1986 in which the PTE application for the subject patent was submitted to the PTO based on…