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…in-person speaker programs. On top of expressing an overall skepticism regarding such speaker programs, OIG expounds upon examples of common violative practices and suspect characteristics. Serra Schlanger, Faraz Siddiqui, Michelle…
…in chemical analysis, or physical testing, and is to be used only for such instruction, law enforcement, research, analysis, or testing.” [(Emphasis added)] “In this case, the drugs at issue…
…of 768 comments submitted by patients, patient groups, advocacy groups, and professional societies, voted in favor of rescheduling. After review of scientific and medical evidence, and other considerations mandated by…
…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…
…1,213 days until December 4, 2011. The ‘507 patent was originally scheduled to expire on August 8, 2008. On March 16, 2005, FDA approved two NDAs for Astellas’s MYCAMINE: NDA…
…“remote processing.” Pharmacists performing remote processing may also receive, interpret, evaluate, clarify, and approve medication orders and prescriptions, including medication orders and prescriptions for controlled substances classified as Schedule II,…
…entry—have been fodder for antitrust concerns for decades (see, for example, our coverage from 2013). Effectively, the first generic filer gets paid not to market—and, as a result of its…
…323.1 (listing “made,” “manufactured,” “built,” “produced,” “created,” or “crafted” in the United States or in America). However, this list is not exhaustive. The final rule does not supersede, alter, or…
…IQOS to Phillip Morris S.A., Marketing Order from Matthew R. Holman, Ph.D., Office of Science Director, Center for Tobacco Products, U.S. Food and Drug Admin., to Philip Morris Products S.A….
…opioid controlled substances that ignored numerous “red flags” of diversion. In addition, the Complaint alleges inappropriate dispensing to numerous individuals, multiple DEA recordkeeping violations, improper alteration of prescriptions, and violations…
…actions that would, to the greatest extent permitted by law: ensure coverage of comprehensive contraceptive care, including all contraceptives approved, granted, or cleared by the Food and Drug Administration, without…
…issued on May 18, 2010, is listed with a “U-642” PUC, defined as “TREATMENT AND PREVENTION OF OSTEOPOROSIS,” and the ‘957 patent, which issued on August 12, 2008, is listed…
…expires. According to Pfizer, “[t]o give effect to the Opinion and Final Order,” the court should, consistent with 35 U.S.C. § 271(e)(4)(A), amend its judgment to add that the effective…
…Covered Entities may pursue “mutually agreed-upon alternative refund arrangements,” such as netting, crediting, or forgiving de minimus or insignificant overcharges. 82 Fed. Reg. 1218, 1220. Manufacturer Civil Monetary Penalties The…
…prevent the plaintiff “from seeking judicial review of FDA’s legal position,” Pl.’s Mot TRO, ECF No. 3, at 4, starting with the FDA denying, without comment on the merits, the…