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…DIMETAPP Extentabs containing 12 mg of brompheniramine maleate and 75 mg of phenylpropanolamine HCL. “In its final order, [FDA] concluded that all extended-release drug products subject to the notice (e.g.,…
By Kurt R. Karst – Last Friday, ISTA Pharmaceuticals, Inc. (“ISTA”) filed a Complaint and a Motion for a Temporary Restraining Order and a Preliminary Injunction in the U.S. District…
…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…
…Modernization Act (“FSMA”). The fees kick in on October 1, 2011. The hourly fee rate is $224 ($335 if foreign travel is required). FDA can be expected to collect fees…
…ones. . . .” (see here and here) GAO Report In its Report, the GAO confirmed much of what on-lookers, industry, and FDA already knew or suspected. The Report cites…
…340B drug payment methodology under the final rule. See Am. Hosp. Ass’n v. Azar, No. 18-2084, 2, 22 (D.D.C. May 6, 2019). As background, under the Social Security Act, CMS…
…despite being in earlier drafts of the SDCA. See FDASIA, Pub. L. No. 112-144, § 1152 (2012); 77 Fed. Reg. 64032 (Oct. 18, 2012); H.R. 1254 112th Cong. (2012). See…
…pursuant to Executive Order (EO) 12866 issued by President Clinton and its predecessor EO 12291 issued by President Reagan. The purpose of that review has been explained by OMB as…
…See, e.g., Warner-Lambert Co. v. Shalala, 202 F.3d 326 (D.C. Cir. 2000). Indeed, Purdue Pharma L.P. (“Purdue”) recently submitted a Petition for Reconsideration (Docket No. FDA-2012-P-0939) after FDA denied without…
…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…
…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…
…feature of the bill. The draft also requires that all compounding pharmacies comply with both USP <795> (non-sterile compounding) and USP <797> (sterile compounding). The draft proposal emphasizes sharing of…
…(D.C. Cir. 1986), cert. denied, 479 U.S. 1086 (1987) (see here). POM then sought to distinguish that case from the POM situation. There was a fascinating exchange between Commissioner Brill…
…concerning preemption: We have determined that the rule will have a preemptive effect on State law. Section 4(a) of [Executive Order 13132] requires agencies to “construe . . . a Federal…
…the U.S. Supreme Court’s January 2007 decision in Medimmune, Inc. v. Genentech, Inc., in which the Court ruled that a dispute must be “definite and concrete” and “real and substantial”…