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…the statute as requiring the sequence: finding, hearing, finding, order. In effect, wrote the Second Circuit, Plaintiffs read the statute to say, “If the secretary finds a drug is not…
CBS News caused a bit of commotion last week in reporting that after a four-year delay, DEA issued a final order revoking Morris & Dickson’s DEA registration. However, until today…
…general information about postmarket surveillance studies (e.g., application number, applicant name, device name, status) and reporting information (e.g., interim and final report schedule, receipt dates, status category), which were listed…
…from recent rulings by the District Court in similar challenges. See Order at 2, Prevor v. FDA, No. 11-1187 (D.D.C. May 8, 2013) (holding plaintiff’s motion to compel FDA to…
…2021, unless DEA receives significant adverse comment. DEA will withdraw the rule by September 20, 2021, if it receives significant adverse comment. Electronic comments must be submitted, and written comments…
…the Executive Order and the OMB memorandum apply to all federal agencies, including FDA, FTC, DEA, CPSC, and USDA. In this post, we will focus on one of those agencies,…
…respect to the company’s Abbreviated New Drug Application (“ANDA”) #77-615 for generic divalproex sodium delayed-release 500 mg tablets. Divalproex sodium delayed-release 500 mg tablets is marketed by Abbott Laboratories under…
…custom device manufacturer. In his May 1st order, Judge G. Kendall Sharp mostly sided with Endotec, Inc., and the two individual defendants, Michael J. Pappas, Endotec’s co-owner and president, and…
…Labs., Inc. v. Thompson, 389 F.3d 1272, 1281 (D.C. Cir. 2004), Dobbs v. Wyeth Pharms., 797 F. Supp. 2d 1264, 1270-71 (W.D. Okla. 2011). In ordering FDA to initiate withdrawal…
…interested parties cannot demonstrate the drugs’ safety, accelerate their compulsory withdrawal. Moving on to the schedule for compliance with the March 22nd Order, Magistrate Judge Francis ultimately adopted FDA’s proposed…
…17th and granted the company 180-day exclusivity. On August 24th, Watson filed an Amended Complaint, and on August 27th, Watson filed a Motion for Summary Judgment asking the court to…
…and issued a cease and desist order restraining POM’s future advertising. On March 8, 2013, POM filed a petition for review of the FTC’s Order in the D.C. Circuit. Surprisingly,…
…Hospira sought, and was granted, a Temporary Restraining Order (“TRO”) that included a stay of FDA’s Letter Decision, rescission of any ANDA approvals predicated upon that Letter Decision, an order…
By Larry K. Houck – Ruth Carter, Chief of the Drug Enforcement Administration’s (“DEA”) Office of Liaison and Policy Section, was among the presenters who addressed the 31st Annual Conference…
On November 27, 2007, the Drug Enforcement Administration (“DEA”) issued a proposed rule to implement a new format for DEA Official Order Forms (so-called “DEA-222s”). DEA requires registrants to acquire…