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…manufacturer’s promotional activities. See Pacira Pharms., Inc. v. FDA, No. 15-7055 (S.D.N.Y. Sept. 8, 2015). Pacira’s allegations are based on FDA’s threatened enforcement as communicated in a September 22, 2014…
…order would impose administrative, civil, and criminal sanctions and regulatory controls applicable to schedule I controlled substances on the manufacture, distribution, possession, importation, and exportation of, and research and conduct…
…FDA. “Ultimately, the question comes down to whether, in each individual case, the applicant has provided sufficient information for the agency to commence its substantive review,” wrote Judge Kollar-Kotelly. Interestingly,…
…on reviewing the PMA submitted by Angiotech’s partner, Cook Medical Technologies, LLC (“Cook). Angiotech, on behalf of the patent owner, Boston Scientific Scimed, Inc. (“BSC”), submitted a PTE application to…
…part of the original complaint. Importantly, FTC said that POM’s request for de novo review of the seventeen ads was made too late, i.e., in POM’s reply brief rather than…
…order cited a number factors in support of that compliance date, including the need to minimize market disruption, and to allow time for submission and review of food additive petitions,…
…Complaint, Ferring alleges that FDA’s actions violate the Administrative Procedure Act, the FDC Act, and the Agency’s regulations. Specifically: First, Ferring contends that the FDA’s prior interpretation, under which PREPOPIK…
By Kurt R. Karst – A few months have passed since the appeals Takeda Pharmaceuticals U.S.A., Inc. (“Takeda”) and Elliott Associates, L.P., Elliott International, L.P. and Knollwood Investments, L.P. (collectively…
…No. FDA-2005-P-0196) asking FDA to revoke the GRAS status of salt, require reduced levels of salt in processed foods, and require “health messages” on retail salt packages. The complaint alleges…
…to be seen. In September 2016, Depomed prevailed in district court patent infringement litigation against three ANDA applicants (see Depomed, Inc. v. Actavis Inc., et al., Case No. 2:13-cv-4507 (D….
…Order 12866. Under the Executive Order, OIRA ordinarily has 90 days to complete its review, with the possibility of one 30-day extension with the written approval of the Director of…
…March 16, 2016. We note that, depending on FDA’s calculations, March 17, 2016 may actually be the applicable date. The triggering of the sunset clause also means that the General…
…covered. Under this revised definition of covered establishment, the menu labeling requirements will now apply to, among others, bakeries, bowling alleys, grocery stores, movie theaters, amusement parks and convenience stores…
…possession, importation and exportation. Schedule I regulatory controls include registration by DEA of legitimate handlers, security to protect against their diversion, specific labeling and packaging, manufacturing quotas, physical inventories, recordkeeping,…
…drug designations. (Indeed, according to FDA’s Orphan Drug Designations and Approvals database, the Agency has granted 50 orphan drug designations since September 6, 2014 – the day after the District Court’s…