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…temporary scheduling of five synthetic cannabinoids: JWH-018, JWH-073, JWH-200, CP-47,497 and cannabicyclohexanol until August 29, 2012. 77 Fed. Reg. 12,201 (Feb. 29, 2012). The temporary scheduling was extended while permanent…
…F. Supp. 2d 30 (D.D.C. 2012), appeal docketed sub nom. Cook v. FDA, Nos. 12-5176, 12-5266 (D.C. Cir. May 31, 2012), came out the other way for FDA when the…
…the drug’s REMS. The pharmaceutical manufacturer is responsible for certifying the health care facilities where the drug can be administered. Typically, the drug is administered only once. In order to…
…the Controlled Substances Act (“CSA”). Schedule of Controlled Substances: Placement in Schedule V of Certain FDA-Approved Drugs Containing Cannabidiol; Corresponding Change to Permit Requirements, 83 Fed. Reg. 48950 (Sept. 28,…
By Kurt R. Karst – Earlier today, The Medicines Company (“MDCO”) announced that the company filed a new Administrative Procedure Act (“APA”) lawsuit in the U.S. District Court for the…
…and policy issues raised by the rule. On Saturday — the very next day — the new discount safe harbor exclusion was also delayed, this time by court order. Earlier…
…New York issued nationwide preliminary injunctions, while the District Court for the District of Maryland issued a temporary restraining order. Each order effectively blocked the MFN rule from taking effect…
…exposure to diverse public comment.” After a temporary restraining order and two preliminary injunctions, it is highly unlikely that the MFN rule will survive as an interim final rule. Therefore,…
…codes . . . enter into a rebate agreement in order to comply with the terms of the NDRA.” (P. 43.) In the same section, a sentence has been added…
…83 Fed. Reg. 12027, 12028 (Mar. 19, 2018). The Acting Administrator noted that there was no evidence in the record as to when the doctor received the OSC. As such,…
…Inc.’s SUBOXONE (buprenorphine and naloxone) Sublingual Film, 2 mg/0.5 mg, 4 mg/1 mg, 8 mg/2 mg, and 12 mg/3 mg (approved under NDA 022410); specifically Dr. Reddy’s Laboratories, Inc. ANDA…
…if a non-infringing alternative exists. Momenta Pharms., Inc. v. Amphastar Pharms., Inc., 686 F.3d 1348 (Fed. Cir. Aug. 3, 2012), the Federal Circuit explained that the safe harbor will still…
…never notifies a company that it is in agreement with its corrective actions outlined in a 483 response. The Agency’s agreement is commonly assumed through Agency silence (e.g., lack of…
…point of 2018 and reminisce about a simpler time, we’ll probably look back on 2018 as a simple time from the vantage point of . . . let’s say 2024….
…Fed. Reg. 8834-8835. Acknowledgement 1 indicates that the submission was received at the ESG. Id. at 8834. Acknowledgement 2 indicates that the submission reached CDRH. Id. Finally, Acknowledgement 3 notifies the submitter…