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…order to find a therapy (e.g., drug, device and/or biologic) that works best for the patient can be just as scary. It would be wonderful if, at the time of…
…must also fail.” The court found FDA’s decision to grant a waiver to InnoPharma pursuant to 21 C.F.R. § 314.99(b) in order to permit the company’s proposed EDTA-containing Acetylcysteine Injection…
…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…
…alleged violation, CDER stated that: “[w]e found that controls on your computerized chromatographic instrumentation were not adequate to prevent analysts from manipulating processing parameters in order to obtain passing results….
…lines for when reviews will be completed, when letters will be issued, or when other actions will be taken. Because workload and competing priorities affect action times, time lines are…
…form available here). The defendant, Barry J. Cadden, was the part owner and head pharmacist at the New England Compounding Center (“NECC”), the compounding pharmacy that shipped contaminated compounded epidural…
By Kurt R. Karst – Even before FDA gave up an appeal of Judge Edward R. Korman’s April 2013 Judgment and Order that Teva Branded Pharmaceutical Products R&D, Inc.’s (“Teva’s”)…
…States International Trade Commission (“ITC”). Without saying as much, Amarin characterizes these players as “cheaters,” and the company is seeking to shut them out of the omega-3 game with respect…
…purchaser. Advisory Opinion 17-3 was requested by a company that manufactures and sells biologics and other products that may be sensitive to temperature changes, direct sunlight or movement, or may…
…a Writ of Mandamus order to compel discovery. The Federal Circuit denied both of these requests as meritless. Disposing of the Motion to Compel Discovery quickly, the Federal Circuit explained…
In a Complaint filed in the U.S. District Court for the District of Columbia last week, United Therapeutics Corporation (“UTC”) alleges that FDA unlawfully denied granting the company a period…
…“a plausible hypothesis that its drug may be clinically superior to the first drug” in order to obtain designation, and must demonstrate clinical superiority to obtain approval of a marketing…
…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…
…request that the court issue an order vacating the IFR and set a compliance date for the final menu labeling rule that is within 15 days of the court’s order….
Numerous prior DEA final orders have been based on a summary disposition. Summary disposition is a procedure used by government counsel to seek a recommended decision by the Administrative Law…