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…under NDA No. No. 020717 to improve wakefulness due to narcolepsy, obstructive sleep apnea, and shift work disorder. The companies filed the lawsuit after FDA “signaled that it may seek…
…necessary. Comments are due by August 10, 2011.) Advertisers should also pay careful attention to how endorsements are provided in the world of online marketing, including blogs, Twitter, and Facebook. …
…Teva Pharms USA, Inc. v. Sebelius, 595 F.3d 1303 (D.C. Cir. 2010), in which the D.C. Circuit was convinced by Teva’s structural argument that the patent delisting counterclaim provision at…
…endosseous dental implant, 78 Fed. Reg. 2647 (Jan. 14, 2013); External cardiac compressor, 78 Fed. Reg. 1163 (Jan. 8, 2013); and Membrane lung devices for pulmonary support, 78 Fed. Reg….
…in court, by seeking a temporary retraining order to block the order from remaining in effect. We expect many companies to request the expedited hearing provided by FSMA. Indeed, we…
…drug Makena. K-V Pharm. Co. v. FDA, 889 F. Supp. 2d 119, 137 (D.D.C. 2012). (the decision was vacated and remanded, citing Cook v. FDA, 733 F.3d 1 (D.C. Cir….
…a 30-month stay on the approval of NDA 208090. See Purdue Pharma LP et al. v. Colleaium Pharmaceutical Inc., Case 1:15-cv-00260 (D. Del. Mar. 24, 2015); Purdue Pharma L.P. et…
…of Facebook’s new policy requiring that pharmaceutical manufacturers, telehealth companies, and online pharmacies apply for permission to advertise on Facebook. This new policy goes into effect on August 25, 2021….
…importation of drugs from Canada. We have reported on several of these laws. Two of these states (Florida and New Mexico) have submitted SIP proposals to FDA. We are watching…
…other things, a group of letters sent by the U.S. House of Representatives Energy and Commerce Committee Oversight and Investigations Subcommittee and the U.S. Senate Finance Committee to myriad public…
…orders to the local DEA office. 21 C.F.R. § 1301.74(b). Suspicious orders include orders of unusual size, orders that deviate substantially from a normal pattern and orders of unusual frequency. …
…L. No. 105-115, 111 Stat. 2296 (1997). In FDAMA, Congress recognized that far too little drug research was being conducted on pediatric populations, and it created an incentive . ….
…18, 2009 ruling), and then denied Sanofi’s request for a stay. See Sanofi-Aventis, et al. v. Sandoz, et al., No. 3:07-cv-2762 (D.N.J. Jun 30, 2009). Sanofi promptly appealed the decision…
…by the injunction. See Mova Pharm. Corp. v. Shalala, 140 F.3d 1060 (D.C. Cir. 1998) (setting forth standard for a preliminary injunction); Sterling Commercial Credit–Michigan LLC v. Phoenix Indus. I,…
…as opposed to Active Pharmaceutical Ingredients) from Canada, by traveling to Canada and purchasing drugs in pharmacies there, or by mail order, either through Internet websites or through telephone purchases. …