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…IVD. These topics have been extensively discussed already. NGS is playing an increasingly prominent role in research and diagnosis. Prior to releasing these draft guidances, FDA held three public meetings…
…Commonwealth from taking any action to implement or enforce the declaration and order. Though down, the Commonwealth was not out. Commonwealth officials went right to work after the district court’s…
…670 (6th Cir. 2007); United States v. Rx Depot, Inc., 438 F.3d 1052, 1063 (10th Cir. 2006); United States v. Lane Labs-USA, Inc., 427 F.3d 219, 236 (3d Cir. 2005)….
…permitted to enter the market. . . . [Additionally,] by obtaining such an order, Mylan intends to extend the 180-day exclusivity period beyond that permitted statutorily . . . . …
…decision in Teva Pharmaceuticals USA, Inc. v. Sebelius, 595 F.3d 1303 (D.C. Cir. 2010), to support the company’s position that it was entitled to relief now, before ANDA approval and…
On September 12, 2008, the U.S. Court of Appeals for the District of Columbia heard oral argument and ruled in Teva Pharmaceuticals USA, Inc. v. Leavitt, which concerns the availability…
…denied Omnicare, Inc.’s motion for summary judgment in the ongoing qui tam case, United States ex rel. Banigan v. Organon USA, Inc., et al. (Case 1:07-cv-12153-RWZ). In their complaint, filed…
By John A. Gilbert, Jr. & Larry K. Houck – A bipartisan group of thirteen congressional representatives penned a letter to Administrator Michele Leonhart last week requesting “clarification, guidance and…
By Kurt R. Karst – Here we are . . . on the eve of Oral Argument before the U.S. Court of Appeals for the Federal Circuit in a dispute…
…any glatiramer acetate injection drug product . . . before the Agency has had an opportunity . . . to fully consider specific data and information in such an application.” …
…No. 077893), Nexgen Pharma Inc. (ANDA No. 077706), Breckenridge Pharmaceutical, Inc. (ANDA No. 077736), and Kremers Urban Pharmaceuticals Inc. (ANDA No. 076652), FDA proposes to deny pending hearing requests and…
…for ANDA approval, the company asked for an amended Order permitting importation of its drug product into the U.S. as a result of a PLAIR request submitted to FDA. The…
…process of Chevron, U.S.A., Inc. v. Natural Resources Defense Council, Inc., 467 U.S. 837, 842 (1984). Finding that the statute does not address what constitutes “overlap” between an NDA holder’s…
…“automatic extrapolation . . . to human beings” should not be disregarded. Id. at 26. The Court questioned why “correlations and inference cannot be drawn” across study reports. Id. Based…
…they “possess[] and rel[y] upon competent and reliable scientific evidence that substantiates” the claim. According to FTC, Hi-Tech continued to promote weight loss products without having the required substantiation. In…