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…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…
…cites a different drug – COL-PROBENECID, a fixed-dose combination drug product containing probenecid (500 mg) and colchicine (0.5 mg) that FDA approved on November 23, 1976 under ANDA 084279 –…
…instance, a drug substance that had never been previously approved was included as part of a fixed-combination drug product (a fixed-combination drug product that did not receive five-year exclusivity because…
…FDA’s response to Pacira’s Motion for Preliminary Injunction was due on October 26, the court issued a revised Scheduling Order on October 22. The Order indicated that the parties are…
…seeking review of an FTC cease and desist order. The FTC Order, issued in 2009, concluded that DCO had made advertising claims that were not substantiated. The Court’s decision concerns…
…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…
…veterinarians can use in compounding in accordance with the draft guidance. In addition, the underlying draft guidance only addresses compounding from bulk substances; it does not apply to the compounding…
…affect more than 200,000 individuals primarily aged from birth to 18 years in the U.S. but for which no drug or biologic treatments are available because a company cannot reasonably…
…general use; custom orders (FDA interprets custom orders narrowly); daily specials; or foods appearing on a menu or menu board for less than 60 days per calendar year. Another change…
…requirements, the Administrator would “take into consideration any comments submitted by the Assistant Secretary with regard to the proposed temporary scheduling order.” Although we are unsure yet whether the Assistant…
…a “Patent Delist Request Flag” – U.S. Patent Nos. 6,248,735 and 6,316,443 (on April 18, 2008) – identifying that the NDA holder has withdrawn the patent and submitted a request…
…by steering transported patients to those [providers] who order their products.” Laboratories are also excluded from the definition of “Eligible Entity”. Other safe harbors: In addition, the OIG proposes to:…
…little clarity about their obligations around the reporting of suspicious orders. A critical element of notice and comment rulemaking is for an agency to solicit important industry input on the…
…existed between the draft guidance and the eCopy Guidance. Pre-Sub Guidance at 6. Applicants should ensure that their Pre-Submissions comply with the requirements of the final guidance document for the…
…seeks to break even more new ground by turning its sights on a new target: synthetic omega-3 oil manufacturers and dietary supplement distributors; and in a new forum: the United…