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…10. 21 CFR 870.5200 External cardiac compressor. 11. 21 CFR 870.5225 External counter-pulsating device. 12. 21 CFR 870.5310 Automated external defibrillator. 13. 21 CFR 872.3640(b)(2) Endosseous dental implant (blade form)….
…proposed Order denying your request for a hearing and withdrawing approval of [your ANDA]. Under 21 CFR 314.200(g)(3), you have 60 days after the receipt of this proposed order to…
…of law upon which the order is based.” 21 C.F.R. §§ 1301.43(e), 1301.46. This summary judgment process used in Wheatland is not commonly exercised by DEA, but may signal a…
…of law enforced by the Federal Trade Commission, and (2) that the enjoining thereof pending the issuance of a complaint by the Commission and until such complaint is dismissed by…
…periods. But President Biden wants that to change. In the July 2021 Executive Order on Promoting Competition in the American Economy, the White House noted that patent laws “have been…
FDA has long taken the position that a Complete Response Letter (“CRL”)—a letter sent when FDA has determined that it “cannot approve” a New Drug Application (“NDA”) or an Abbreviated…
…and Radiological Health (“CDRH”)’s March 30, 2011 order that rescinded the company’s 510(k) clearance of a collagen scaffold device, marketed as Menaflex.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…
…May 2014, FDA denied the requests for a hearing and issued an order withdrawing approval of the PEG-3350 ANDAs. But FDA didn’t finalize that Order for another 4 years. That’s…
By Carrie S. Martin – Yesterday, the Federal Trade Commission (“FTC”) held a press conference in Chicago to announce a lawsuit against several companies, including Central Coast Nutraceuticals, iLife, Simply…
In September 2022, while the world was still in the midst of the COVID-19 epidemic and dealing with significant supply chain woes, President Biden issued an Executive Order—Executive Order 14081—titled…
…practice.” 21 U.S.C. § 353(f)(1). Generally, an “order” is “lawful” if it is a prescription or, if an oral order, it is both promptly reduced to writing and filed by…
…a term of settlement, to jointly request that the court vacate its August 7, 2015, Order granting Amarin’s PI Motion. We certainly think vacating the court’s August 7 Order could…
…by administrative order. 21 U.S.C. § 360c(e)(1)(A)(i). Practically speaking, issuing an administrative order may be less burdensome for FDA than issuing a reclassification regulation because an administrative order does not…
By Kurt R. Karst – Last Friday, ViroPharma Incorporated (“ViroPharma”) filed a Complaint and a Motion for Temporary Restraining Order And/Or Preliminary Injunction in the U.S. District Court for the…
…States, and release into domestic commerce, of any future shipments of foreign-manufactured API for use in compounding non-customized 17P except in certain specified instances.” FDA argued that the Complaint should…