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…a wide range of applications. Indeed, FDA’s consideration of OTC collection to reduce “barriers” could have implications for OTC devices generally. Getting self-collection devices through the FDA will probably not…
…determination of therapeutic equivalence for a generic drug product and protection of intellectual property rights accorded an NDA holder. . . . [T]his approach reduces the potentially confusing proliferation of…
…but instead will address their status “either after completion and analysis of ongoing studies to address the safety and effectiveness data gaps . . . or at a later date,…
…on SCLP sales requirements. 21 U.S.C. § 830(e)(1)(B)(i). Regulated sellers must renew their self-certification annually for each place of business where they sell SCLPs. 21 C.F.R. § 1314.40(b). Mail-order distributors…
…the U.S. Constitution and violates 42 U.S.C. § 1983. These are the same counts alleged in the Alameda County lawsuit. According to the Complaint: The Regulation represents a per se…
…Regenexx Procedure is performed within the borders of Colorado. FDA countered that this procedure was introduced into interstate commerce because one or more of its components is shipped via interstate…
By John A. Gilbert & Karla L. Palmer – On October 12th, President Obama signed into law the “Combat Methamphetamine Enhancement Act of 2010” (Public Law No: 111-268) (“Enhancement Act”). …
…provisions. California 1. Senate Bill 17 (enacted Oct. 9, 2017) (see our blog post here) Effective Jan. 1, 2018, requires a manufacturer of a prescription drug whose cost of therapy…
…use. According to a House report, the excise tax, if it goes into effect, “will adversely impact the industry . . . , increase the cost of healthcare, slow medical…
By Kurt R. Karst – Earlier this week, a group of five tobacco companies (R.J. Reynolds Tobacco Company, Lorillard Tobacco Company, Commonwealth Brands, Inc., Liggett Group LLC, and Santa Fe…
…(H.R. 6160) – that is intended to direct companies “to invest in research and production to formulate tamper resistant drugs in order to compete with drugs of a similar nature…
…owned by PBMs) are retail and included in AMP (pages 172-199). Sales to hospitals for inpatients continue to be non-retail. Sales for use in the hospital outpatient pharmacy are retail…
…rule curbing promotion and sale of cigarettes and smokeless tobacco to underage consumers. In anticipation of that date, FDA has issued the following guidance documents: Compliance with Regulations Restricting the…
…District of Pennsylvania stated in dicta in its May 2006 opinion in Colacicco v. Apotex, Inc., 432 F. Supp. 2d 514 (E.D.P.A. 2006) (which is on appeal to the U.S….
…language in the FDCA pre-dates the Supreme Court’s Wickard v. Filburn, 317 U.S. 111 (1942), decision and is therefore meant to reflect a pre-Wickard reading of interstate commerce. As such,…