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…without the opportunity for public comments. It shares many of the same requirements of the CGDP: manufacturers must provide and maintain updated information on their labeler codes and NDCs; they…
…the parties in 2000. In part, that order requires Lane Labs’ health-related marketing claims to be substantiated by competent and reliable scientific evidence. The district court found that Lane Labs’…
By JP Ellison – Traditionally, challenges to a Drug Enforcement Administration (“DEA”) immediate suspension order (“ISO”) have been litigated, in the first instance, in federal district courts. This is true even…
…the U.S. District Court for the District of Columbia that stymied the company’s efforts to “restore” orphan drug exclusivity for the pre-term birth drug MAKENA (hydroxyprogesterone caproate) Injection, 250 mg/mL,…
…Eric Holder to commence an investigation into whether the New England Compounding Center (“NECC”) violated the federal Controlled Substances Act and its implementing regulations. The letter states that NECC shipped…
…submitted. Sponsors are encouraged to collect data in the following order: structural and functional characterization, nonclinical evaluations, human pharmacokinetic and pharmacodynamic studies, clinical immunogenicity studies, clinical safety studies and when…
…component, part, or accessory of a tobacco product (except for raw materials other than tobacco used in manufacturing a component, part, or accessory of a tobacco product).” Option 2 of…
…mind or tested in a representative number of women. In celebration of the OWH anniversary, FDA Commissioner Dr. Robert Califf, and Associate Commissioner for Women’s Health and Director of the…
…NAD’s policy and the FTC’s approach. According to Mr. Peeler, both the NAD and FTC begin from a common starting point: the legal requirement that all objective claims in advertising…
…This means that order counts, and that to obtain NCE exclusivity for a combination drug containing new and old actives, the NCE component must be approved first, followed by the…
…from the Federal Trade Commission – “Generic Drug Entry Prior to Patent Expiration: An FTC Study” – that highlighted the problem of, among other things, the submission of inaccurate patent…
…for Direct to Consumer (DTC) Genetic Testing: IVDs. 78 Fed. Reg. 66746, 66746 (Nov. 6, 2013). In sum, there are many regulatory challenges that still face companies developing personalized therapies…
…proposed rule CFS strongly objected to FDA’s proposal: Defendants’ proposal utterly fails to comply with the Court’s Order and FSMA… A deadline is a deadline, a firm parameter with meaningful…
…claims unless such claims are substantiated by competent and reliable scientific evidence. The FTC alleged that certain advertising claims subsequently made by GOL were not supported by “competent and reliable…
…Perhaps a 505(b)(2) application containing verly little data and that is granted priority review could be turned around in short order. With the enactment of the Generic Drug User Fee…