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…8126. Under the latter statute, manufacturers of “covered drugs” (generally, prescription drugs approved under a new drug application) must, in order for their outpatient drugs to be federally reimbursed under…
…of Cobalt’s Complaint, Cobalt’s Motion for Temporary Restraining Order, FDA’s Opposition Memorandum, and Cobalt’s Supplemental Memorandum are available via the hyperlinked text. We understand that on May 9th the court…
…Ten Reasons in chronological order of the letters and in order of their appearance in those letters. Letter 1 is signed by former DEA administrators and Directors of National Drug…
…prescription drugs, including but not limited to, owned, acquired, affiliates, brother or sister corporations, operating subsidiaries, franchises, business segments, part of holding companies, divisions, or entities under common corporate ownership…
…restitution. On the Commission’s motion, the district court issued a temporary injunction, froze Brown’s assets, and appointed a receiver to manage his company. Brown and the Commission later filed cross-motions…
…Court Orders Puerto Rico Pharmaceutical Distributor to Pay $12 Million in Connection with Alleged Failure to Report Suspicious Orders of Pharmaceutical Drugs and Other Controlled Substance Violations, Nov. 6, 2023…
…Reconsideration of a pre-Levine Order granting Perrigo’s Motion for Summary Judgment. The pre-Levine Order found that Gaeta’s state law causes of action were preempted to the extent that they allowed for…
…policy that in order for two drug product to be in the same “dosage form,” they must share the same Orange Book dosage form descriptor, and that a drug product’s…
…to FDA, the company must first conduct studies comparing its proposed product to the brand-name reference product. In order to do so, the generic drug manufacturer must first obtain reference…
…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…
…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…veterinarians can use in compounding in accordance with the draft guidance. In addition, the underlying draft guidance only addresses compounding from bulk substances; it does not apply to the compounding…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…
…ruled that Maine’s 2013 law, titled “An Act To Facilitate the Personal Importation of Prescription Drugs from International Mail Order Prescription Pharmacies,” 2013 Me. Legis. Serv. Ch. 373 (S.P. 60)…
…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…