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…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…
…interpretations. Together these two guidance documents finalize and consolidate four draft guidance documents: “Same Surgical Procedure Exception under 21 CFR 1271.15(b): Questions and Answers Regarding the Scope of the Exception”…
…of Controlled Substances: Temporary Placement of Fentanyl-Related Substances in Schedule I, 82 Fed. Reg. 61700 (Dec. 29, 2017). DEA has temporarily scheduled other substances fentanyl-related substances over the past four…
…an end-run of the court’s order. But in his 22-page February 13th Memorandum Opinion, Judge Contreras said that he is not persuaded by Ferring’s arguments: Ferring [] argues that the…
…here). However, if the rule is finalized, the implementation date and the effective date would both be January 1, 2019. The proposed rule requests comments on the new effective date…
With one paragraph in a Summary Judgment Order issued last week, the Northern District of California further expanded the patent safe harbor under 37 U.S.C. § 271(e)(1). Though not a…
…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…
…under the Single Convention, Epidiolex should be placed in schedule V of the CSA.” DEA confirmed in the Final Order that it is imposing additional regulatory requirements to ensure compliance…
…Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act” (“SUPPORT for Patients and Communities Act”), we decided to revisit and update our old “waistline” post numbers. With…
About 6 weeks after Vanda filed its complaint, the company’s lawsuit has joined its clinical trial: on hold. Last week, the District Court of D.C. granted FDA’s motion for a…
…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…
…appears that bis-(p-hydroxyphenyl)-pyridyl-2-methane (BPHM, CAS: 603-41-8, UNII: R09078E41Y), the active moiety of sodium picosulfate (CAS: 10040-45-6, UNII: VW106606Y8), also seems to be the active moiety in bisacodyl [(4,4’-diacetoxydiphenyl(2-pyridyl)methane), CAS: 603-50-9,…
…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…
…infringement litigation over generic KALETRA (lopinavir; ritonavir) Tablets. Under FDC Act § 505(j)(5)(B)(iii), the 30-month stay may be “for such shorter or longer period as the court may order because…
…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…