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…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…
…molecules or large molecules. Thus, FDA’s regulations at 21 C.F.R. § 316.3(b)(14) define the term “same drug” to mean the following: (i) If it is a drug composed of small…
…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….
…changed course in favor of notice and comment rulemaking before, or after, the November 8th Presidential election. While engaging in notice and comment rulemaking strengthens the agency’s hand in the…
…for an identified individual patient, limited compounding before the receipt of such a prescription (referred to as “anticipatory compounding”), and the prohibition on compounding for office use (referred to as…
…the present matter, DEA issued an Order to Show Cause to the physician in September 2016, proposing the denial of the physician’s application for DEA registration on two separate grounds:…
…dispute concerns a rarely litigated statutory provision: 6-month pediatric exclusivity granted (or denied, as the case is here) under the Best Pharmaceuticals for Children Act (“BPCA”) (FDC Act § 505A)….
…Halil, M.D., 64 Fed. Reg. 33319, 3320-21 (June 22, 1999); William E. Brown, D.O., 58 Fed. Reg. 64004, 64005 (Dec. 3, 1993). The plain language of the statute suggests a…
…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…
…– whether the order in which an other applicant obtains a court decision and tentative approval counts – FDA answers this question in the following hypothetical: A hypothetical example illustrates…
…for the District of Columbia Circuit the Final Judgment and Order entered on September 5, 2014 by the U.S. District Court for the District of Columbia in Depomed Inc. v….
…violation. CSPI’s complaint is similar in substance to the complaint filed by Dr. Fred Kummerow in 2013 alleging that FDA violated the APA when it failed to respond to his…
By James E. Valentine* & Sara A. Khan** – On July 11, 2014, the House Energy and Commerce’s Subcommittee on Health held its fourth hearing, as part of its 21st…