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…Complaint in May 2011 seeking to compel FDA, by a court-ordered deadline, to withdraw approval for subtherapeutic uses of penicillin and tetracyclines in animal feed and to issue a final…
…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…
…with respect to the composition claims of the Composition Patents. Finally, to the extent that Watson is not entitled to exclusivity with respect to the Combination Therapy Patents, it is…
…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,…
…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…
…the Commonwealth’s ban on FDA-approved ZOHYDRO ER (hydrocodone bitartrate) Extended-release Capsules is unconstitutional because the ban violates the Supremacy Clause of the U.S. Constitution (as well as the dormant Commerce…
…in their Complaint that FDA, in violation of the Administrative Procedure Act (“APA”), failed to comply with the Agency’s statutory duty to withdraw approvals of subtherapeutic uses of penicillin and…
…this brief provides the clearest statement of FDA’s limited authority to compel a recall. We previously described (here and here) the litigation commenced by Hospira, Inc. (“Hospira”) wherein the company…
…at the agency and the Office of Diversion Control. Ms. Carter stated that the agency is considering issuing further clarification of suspicious order requirements, possibly a regulation specifying the format…
…rules under the Executive Order by November 26, 2020, absent a waiver. See M-20-31, Implementation of Section 6 of Executive Order 13924 (Aug. 31, 2020). There is no doubt that…
…503B outsourcing facilities. Typically, applicants must personally appear before the Non-Resident Application Review Committee, but this Order allows for a remote interview of the applicant by Board staff. Temporary permits…
…(or worker’s compensation) is another red flag. The expert explained that insurance companies frequently reject suspicious controlled prescriptions that may be related to drug abuse or diversion, for example prescriptions…
…ORDER (Entered: 08/19/2014)) scheduling an emergency hearing on the Motion for Temporary Restraining Order for Tuesday, August 19, 2014 at 3pm in Courtroom 2C. ORDER directing that the decision of…
On June 6, the Eleventh Circuit vacated the Federal Trade Commission’s (“FTC’s”) data security-related cease and desist order against LabMD, Inc. (“LabMD”), a diagnostic testing company. The decision was less…
…FDA proposed that, to be a valid prescription order for a compounded drug product, the prescription order needed to state clearly that it is for a compounded drug and necessary…