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…Apotex’s Complaint for lack of a case or controversy. Citing and quoting the U.S. Supreme Court’s decision in MedImmune, Inc. v. Genentech, Inc., 549 U.S. 118 (2007), the Federal Citcuit…
…October 6, 2016, FDA published in the Federal Register a Final Rule, titled “Abbreviated New Drug Applications and 505(b)(2) Applications,” that will forever alter the Hatch-Waxman landscape, and that will…
…RCTs in any litigated case. Commissioner Rosch disagreed, stating that the FTC required RCTs many years ago in Thompson Medical Co., 104 F.T.C. 648, 842-43 (1984), aff’d, 791 F.2d 189…
Hyman, Phelps & McNamara, P.C. is co-hosting a complimentary webinar, with Five Rivers Rx, on DEA compliance during the current opioid epidemic. The webinar is scheduled for November 15, 2018…
…summary, the district court dismissed PhRMA’s original Complaint on procedural grounds, without prejudice, granting PhRMA leave to amend its Complaint within 30 days. Granting, in part, California’s Motion to Dismiss,…
…IV Commitment Letter were relatively minor appeared to have been addressed in the September 2017 version of the guidance. In addition, the MDUFA IV Commitment Letter stated, “FDA will continue…
…Masters Pharmaceutical, Inc. v. Drug Enforcement Administration, 861 F.3d 206 (D.C. Cir. 2017), where the court set forth new and significant suspicious order monitoring and reporting requirements, the industry still…
…the Supreme Court’s decisions in Sackett v. EPA, 132 S.Ct. 1367 (2012), Bennett v. Spear, 520 U.S. 154 (1997), and Abbott Labs v. Gardner, 387 U.S. 136 (1967), and, “if…
…previous posts here, here, here, and here; and comment here). A brief recap: In the 1980s FDA attempted to keep dietary supplements, other than traditional vitamins and minerals, off the…
…Substances Act (“CSA”). The temporary scheduling will expire on April 20, 2013, or upon completion of rulemaking proceedings, whichever occurs first. 77 Fed. Reg. 64,032 (Oct. 18, 2012). DEA also…
…§ 351(l)(2), is not mandatory.) In Sandoz, however, Sandoz did not partake in the patent dance. Apotex decided otherwise and engaged Amgen in the dance. Apotex, like Sandoz before it,…
…15, 2022. Human blood, human plasma, [and] human tissues are not included within the scope of the Amended Sectoral Annex.” As some of our readers may recall, we blogged about…
…selling herbal supplements, which, it is alleged, are illegal misbranded drugs. Judge Danny Reeves of the federal district court in Lexington, Kentucky, issued a very brief order, but some of…
…Enroflox™ 100, a generic version of Bayer’s fluroquinolone animal drug Baytril® 100 (enrofloxacin) Injectable Solution, has paid off. FDA, following an April 12, 2013 Order from the U.S. District Court…
…violates the Administrative Procedure Act’s (APA) minimal notice requirements and deprives aggrieved parties of due process. We note that in a final order published last Friday, Paul E. Pilgram, M.D.,…