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…the answers. (You can e-mail me your answers at kkarst@hpm.com) Q1: Who said “So, when you add it all up, this bill will provide regulatory relief, increased competition, economy in government,…
…has reason to know” that the prescription is invalid. Holiday CVS, L.L.C. d/b/a CVS/Pharmacy, Nos. 219 and 5195; Decision and Order, 77 Fed. Reg. 62,316, 62,342 (Oct. 12, 2012). “[W]hen…
…FDA hopes to complete its review of these issues and the administrative reconsideration process by May 30, 2008. Until then, further litigation is stayed. It is unclear what, exactly, the…
…dosage form, route of administration, strengths, etc.); Information detailing the need for the animal drug products that will be compounded with the bulk drug substance. FDA states that to be…
…“knowingly or intentionally delivers, distributes, or dispenses, or offers or attempts to deliver, distribute, or dispense, a controlled substance by means of the Internet” but does not include registered manufacturers…
…computerized controls to prevent data manipulation, and, despite that, they failed to take sufficient corrective action to prevent the recurrence of these problems. Indeed, CDER details the firm’s receipt of…
…exclude (1) price concessions (if not passed through to retail pharmacies) and direct sales to PBMs, managed care organizations, HMOs, insurers, long term care providers, and mail order pharmacies not…
…possible, however, that with the prospect of paying a backlog fee, ANDA sponsors will withdraw some pending ANDAs before October 1, 2012, thereby decreasing the ANDA backlog andincreasing the per-ANDA…
…of 180-day exclusivity. See, e.g., Ranbaxy Labs., Ltd. v. Leavitt, 459 F. Supp. 2d 1, 3-4 (D.D.C. 2006). Ultimately, we cannot Predict whether the Amarin case will be settled or,…
…and Radiological Health (“CDRH”)’s March 30, 2011 order that rescinded the company’s 510(k) clearance of a collagen scaffold device, marketed as Menaflex. The petition for review is the most recent…
…drug and biosimilar competition beyond that reasonably contemplated by applicable law.” In September 2021, FDA did just that. On September 10, 2021, then-Acting Commissioner of FDA, Janet Woodcock, sent a…
…at its discretion, award a six-month extension, which, in turn, would extend the Agency’s review goal date). 21 C.F.R. § 314.110(c). Essentially, FDA’s position postponing the reviewability of CRLs can…
…or not, depends on context,” King v. St. Vincent’s Hosp., 502 U.S. 215, 221 (1991). Moreover, noted Judge Gilstrap, citing to a letter FDA sent to Allergan, “FDA has expressly…
…announced that the U.S. District Court for the Northern District of Illinois, Eastern Division, granted the FTC’s request for a temporary restraining order on August 6, 2010, requiring the companies…
…of hundreds of millions of dollars to patients and other purchasers.” Complaint at 2, No. 1:17-cv-00131 (D. Del. Feb. 7, 2017). Last Tuesday, the FTC’s unfair competition case against Shire…