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…“nonclinical laboratory studies, clinical studies, dosage form development, record and report maintenance, meetings with FDA, determination of patentability, preparation of designation request, IND/marketing application preparation, distribution of the drug under…
…inspections, certification of facilities and accreditation of laboratories, and mandatory notification and recall, among others. FDAGA 2009 retains these and adds others, including: • All facilities would be required to develop…
…concern 14 narcotic drug products, including morphine sulfate, hydromorphone, and oxycodone. The Warning Letters direct the companies to stop manufacturing and distributing the specific narcotic drug products in certain dosage…
…drug UBRELVY (ubrogepant) that features tennis star, social media influencer and entrepreneur Serena Williams. This letter, dated August 29, 2024, (at the height of the US Open, no less) comes…
…The Proposed Rule states that Stage 4 and Stage 5 would not begin before October 1, 2027, and April 1, 2028, respectively, in order to enable laboratories to participate in…
…federal court, the Commission would have been much better off staying “home” in Shire. Instead, the FTC took a strong position before the Third Circuit, arguing that Section 13(b): (1)…
…is worth noting that FDA has authority to order mandatory device recalls and repair, replacement or refunds (and reimbursement of expenses in complying with the order). This authority is set…
…The amended order limits the court’s previous order to the failure-to-market forfeiture provision at FDC Act § 505(j)(5)(D)(i)(VI) and notes that FDC Act § 505(j)(5)(D)(i)(VI) “was not raised in [Teva’s] Complaint,…
…Endotec’s ankle and jaw implants, but not its knee implants, were exempt “custom devices.” On March 30, the Eleventh Circuit affirmed in part and reversed in part, concurring that the…
…The court’s order vacates the district court’s April 11, 2008 injunction and reverses the court’s order. Also, in a rather unusual move, the court issued its mandate on September 12,…
…the company’s reconsideration request. With respect to Apotex, FDA refers to a May 7, 2007 letter answer the Agency sent to the company. In that letter, FDA declines to immediately…
… RELATED READING: April 5, 2007 Orange Book Blog Post UPDATE: Earlier today, the U.S. District Court for the District of Columbia issued an order extending from April 11, 2007…
…Part APP Pharmaceuticals, LLC’s (“APP’s”) appeal related to Judge Claude M. Hilton’s August 3, 2010 decision. Briefly, FDA approved ANGIOMAX at 5:18 PM on Friday, December 15, 2000 under New Drug…
…to Dismiss at 9, PhRMA v. Brown, No. 2:17-cv-02573 (E.D. Cal. Jan. 26, 2018) [hereinafter Memorandum]; see also Ex Parte Young, 209 U.S. 123, 157 (1908). In the present matter,…
On December 11, 2018, the authors of this blog post attended the oral argument in Federal Trade Commission v. Shire ViroPharma, Inc., No. 18-1807 (3d Cir. filed Apr. 12, 2018)….