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…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…
…commercial funding, ACCME is now requesting comments on two proposals that create two new designations and review processes for providers of CME programs – the “Commercial Support-Free™ Accredited CME” and…
…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…
…statutory language, the judge in Minnesota overseeing multi-district device litigation granted the plaintiffs’ motion to amend their complaint to comply with the Court’s recent ruling in Wyeth v. Levine. The…
…District Court dismiss this action under Fed. R. Civ. P. 12(b)(6). Magistrate Judge Wilson found that although the qui tam relators’ amended complaint had gone into detail about allegations of…
…quick review of the options available to companies to request user fee waivers and reductions seems in order. Under PDUFA, FDA collects three types of user fees for a drug…
…and order FDA to suspend ANDA approval. Valeant also seeks a Temporary Restraining Order (“TRO”) compelling FDA to suspend ANDA approval. (Valiant’s TRO is filed under seal.) FDA, as the…
…approve the company’s ANDA for a generic version of Abbott Laboratories’ DEPAKOTE (divalproex sodium) Delayed-Release Tablets, 500 mg. In January 2008, the U.S. District Court for the District of Columbia…
…company is liable to someone who was injured by their product if that product was approved by FDA based on false information the company submitted and the company has admitted…
…a healthcare reform bill has cleared the HELP Committee, but the Finance Committee has yet to complete legislation. If and when the Senate passes a bill, differences from the House…
…a practitioner who is licensed by a State to compound or order compounding for a drug described in subparagraph (A), and is compounded in accordance with that State’s law, for…
…support the company’s position. Mylan’s petition acknowledges, however, that FDA’s regulations “would allow delisting after patent expiration,” but notes that the company is challenging FDA’s position that 180-day exclusivity ends…
…the counterclaim provision do not authorize an order compelling the patent holder to change its use code narrative.” (See our previous posts here and here) Caraco has filed a petition…
…interpretations of the forfeiture provisions.” Upsher-Smith Laboratories (“USL”) and Teva Parenteral Medicines (“Teva”) submitted comments to docket #2007N-0417. (The deadline for submitting comments to the docket has been extended from October…
…will consider the “potential” as compared to commercially available alternatives. Another element of the definition is that a device be a “breakthrough technology.” When considering this prong, the Agency will…