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…approved in capsule, tablet, and oral solution dosage forms for the treatment of partial seizures associated with epilepsy and for the management of post-herpetic neuralgia. The complaint (amended) in the…
…yet been approved), follows almost identical Advisory Opinion Requests filed in January 2005 by GlaxoSmithKline (Docket No. 2005A-0015), in August 2006 by AstraZeneca (Docket No. 2006A-0318), and in June 2007…
…defendants allegedly used a national marketing scheme to promote a fraud. If true, they should not get off scot-free if there is a practical statistical way to address the difficult…
…charges the defendants with criminal conspiracy, mail fraud, wire fraud and violations of the Federal Food, Drug, and Cosmetic Act. In plain English the defendants are alleged to have falsified…
…Manufacturers Focus meeting in Los Gatos, CA last October, FDA reported that it had granted 95 breakthrough requests (it’s unclear if this is just since the statutory change or also…
…is not clear that this will be of any real value. In addition, the guidance adds that decisions regarding breakthrough decisions (granting/denial) are considered significant decisions, which can be appealed…
…in the Los Angeles District, were intended for use in the manufacture of starting material for the development of active pharmaceutical ingredient – the subject of a pending Abbreviated New…
…for discussing complex legal and regulatory issues associated with food, drugs, cosmetics, medical devices, and other health-related products. 2024 brings a host of HPMers who have important roles at FDLI…
With the expanding market for plant-based foods, often developed as an alternative to the animal-based food products which consumers avoid for various reasons (allergies, health concerns, ethical concerns, environmental concerns,…
…salmon before approval. The plaintiffs demanded that FDA provide them these internal deliberative documents, and the U.S. District Court for the Northern District of California agreed, issuing an order requiring…
…do not have a judicial process, there are significant technical and procedural safeguards in place, with processes negotiated with unions. The U.S. Anti-Doping Agency (USADA) also follows extensive policies and…
…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…
…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”…
…things, the PTO cited Unimed, Inc. v. Quigg, 888 F2d 826; 12 USPQ2d 1644 (Fed. Cir. 1989), in which the Federal Circuit addressed the timeliness of a PTE application submission…
…outreach; Identifying additional sources of diversion; Collaborating investigations with state and local entities; Expanding the use of Tactical Diversion Squads (“TDSs”) (comprised of DEA diversion investigators and special agents, state…