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…been mulling CDSS guidance for the past few years. However, it has never issued draft guidance. The closest FDA has come is the Mobile Medical Apps guidance (Feb. 2015), which…
…between FDA and Senators Hatch and Harkin, Commissioner Hamburg committed to issuing a revised draft in order to address the concerns of Congress and industry. Four years later, in August…
…in the final decision.” U.S. Dept. of Justice, Attorney General’s Manual on the Administrative Procedure Act 80 (1947) (Wm. W. Gaunt & Sons, Inc., Reprint 1979). In accordance with the…
…to equal protection and due process.” That argument failed. Next, the defendant contended that “people of ordinary intelligence cannot understand what 21 U.S.C. § 352 means.” The prohibition on distribution…
…1998 U.S. – E.U. Mutual Recognition Agreement, with a view to avoiding duplicative inspections and saving millions of dollars in repetitive inspections. FDA has stated that they believe this “…initiative…
…their patients.” (FN 5). FDA notes that hospital compounding and distribution varies: Some compound only for use and administration within the hospital and others compound for distribution throughout a broader…
…approval requirements. According to the complaint, counsel for the company asked FDA counsel “to identify the statutory or regulatory basis” for the rescission order, to which agency counsel declined to…
…patent. Citing legislative history and the Federal Circuit’s decision in Somerset Pharmaceuticals, Inc. v. Dudas, 500 F.3d 1344 (Fed. Cir. 2007), the PTO concluded that an interim extension cannot be…
…2003 Medicare Modernization Act (“MMA”), Pub. L. No. 108-173, 117 Stat. 2066, and 12 years and about 10 months after the MMA’s enactment, we finally have new Hatch-Waxman regulations. On…
On January 14, 2008, Nu-Pharm Inc., a Canadian drug company formerly owned by Apotex, Inc., filed a complaint in the U.S. District Court for the District of Columbia against FDA…
…accompanying memorandum, the company states “[n]ow that the FDA has delisted the Pfizer patent, Mylan’s claim to 180-day exclusivity has moved to the forefront. . . . Mylan is likely…
…exclusivity expires on September 23, 2007. Mylan’s arguments hew closely to those the company made in its Emergency Application. On March 21, 2007, Pfizer submitted two petitions (Docket Nos. 2007P-0110…
…Commission (“FTC”) Consent Order by marketing Relacore and Relacore Extra. Defendants agreed to the FTC Consent Order in 2006 for claims made for a different weight loss product. That Order…
…Justice) filed an injunction suit against Franck’s Lab, Inc. and others (collectively “Franck’s”) in the Middle District of Florida. Franck’s compounds veterinary drugs for non-food producing animals. On July 1,…
…Section 519 of the FDCA. 82 Fed. Reg. at 60923. It also acknowledges the benefits of summary reporting for lower risk devices. Id. at 60924. Specifically: The pilot demonstrated several…