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…Fiscal Year 2011 Financial Services and General Government Appropriations Bill (S. 3677). That appropriations bill was ultimately included as part of the Continuing Appropriations Act of 2011 (Pub. L. No….
…is based on the ratio of its branded drug sales to the branded drug sales of all covered entities during the prior year. Branded drug sales are sales of brand…
By Ricardo Carvajal – The D.C. Circuit Court of Appeals upheld the D.C. District Court’s grant of an injunction that bars FDA’s regulation of e-cigarettes as drug/device products absent claims…
…Circuit decision stands, companies would have little choice but to disclose all adverse event reports. The resulting flood of information could confuse and mislead both investors and consumers. Although most…
…not preempted. The second draft guidance document consists of commonly asked questions and answers about implementation of PPACA § 4205. Topics include what establishments are covered by the law, which foods…
…of the fundamental challenges for CDRH. The concept is commendable. The problem is that communicating “expectations” after they have been set is not very helpful. Companies need advance notice of…
…No. 111-238; pages 144-148 & 150-151) accompanying the Fiscal Year 2011 Financial Services and General Government Appropriations Bill (S. 3677). The action follows testimony given by Federal Trade Commission (“FTC”)…
…restaurants and retail food establishments with 20 or more locations doing business under the same name and offering for sale substantially the same menu. In return, such larger chain restaurants…
…5-4 landmark consolidated decision in PLIVA Inc. v. Mensing (Docket No. 09-993), Actavis Elizabeth, L.L.C. v. Mensing (Docket No. 09-1039), and Actavis, Inc. v. Demahy (Docket No. 09-1501) (and for…
…the Federal Controlled Substances Act (“CSA”) three synthetic cathinones. 75 Fed. Reg. 55616 (Sept. 8, 2011). The action is based on a finding by the DEA Administrator that the substances…
…metabolic syndrome, tooth decay, and gout. They claim that sugar-containing drinks are the single biggest source of added sugars and calories in the American diet. Consumption data show that Americans,…
…the Florida district court’s judgment, and remand the case with instructions to dismiss the complaint. That’s unfortunate. As Hyman, Phelps & McNamara, P.C.’s Karla L. Palmer and Jeffrey N. Gibbs…
…the point of use (id. § 806.2(i)). A correction or removal should be conducted under the procedures in 21 C.F.R. Part 7. It also must be reported to FDA within…
…hospitals, hospital pharmacies, and compounding pharmacies that prepare drugs or devices for their own patients (4). Compared with the proposed rule, the reporting burden is reduced for companies that only…
By Kurt R. Karst – As if on cue after our post yesterday concerning briefing in FTC v. Watson Pharmaceuticals, Inc. (Docket No. 12-416), where the U.S. Supreme Court will…