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…the diagnosis, cure, mitigation, treatment or prevention of disease, 21 U.S.C. § 321(h)(2), but which, presumably unlike a drug, ‘does not achieve its primary intended purposes through chemical action within…
…work. The Forbes article quotes Ramsey Baghdadi, an editor of the RPM Report, who correctly sees FDA’s Plan B decision at the “intersection of science, politics, and policy.” FDA’s leaders…
…code counterclaim case, Caraco Pharmaceutical Laboratories, Ltd. v. Novo Nordisk A/S (Docket No. 10-844) (see our previous post here), we thought we’d tee up another case, pending before the Federal…
…other FDA actions related to BPCA-requested or PREA-required pediatric studies (for the period from July 1, 1998, through December 31, 2010) and considering other data and information, a committee appointed…
…the lot or serial number. Until recently, FDA solicited general public comment and held public workshops, but not much more (see here). In particular, FDA had not issued a proposed rule. …
…lessons to be gleaned from that case. Bayer entered into a consent decree with the FTC in 2007, which prohibited the company from making any representation about the benefits, performance,…
By William T. Koustas – We have been following the litigation between Regenerative Sciences, LLC (“Regenerative”) and FDA for over two years (see here, here, here, here, and here. On…
…§ 271(e)(1). In coming to its decision, the District Court relied on the U.S. Supreme Court’s decision in Merck KGaA v. Integra Lifesciences I, Ltd., 545 U.S. 193 (2005), and…
…here, would entitle brand pharmaceutical companies, as a matter of law, to manipulate the FDA regulatory process and undermine state and federal laws that encourage generic competition,” writes the FTC….
…“a listed chemical or any chemical, substance, or item on a special surveillance list published by the Attorney General, which contains chemicals, products, materials, or equipment used in the [illicit]…
…products. In a footnote, the Agency clarifies why the one exception to this rule, the Rx monograph for prescription radioactive drugs for basic research, 21 C.F.R. § 361.1, is not…
…the person responsible for its labeling) markets, promotes, labels, or advertises the software for diagnosis, prevention, or treatment of disease or other conditions (e.g., stroke, pregnancy, high blood pressure, migraines)….
…Certuss-D, and Trexbrom, FDA’s Warning Letter states: Certuss, Certuss-D, and Trexbrom contain the active ingredient chlophedianol, which is an acceptable antitussive active ingredient. However, chlophedianol cannot be combined with the…
…17, 2015 v. FDA review of comments, data, and information; drafting of the final monograph; and final review and approval by FDA, Department of Health and Human Services, and Office ofManagement…
…passed on June 20, 2013, and, according to an implementation timeline, requires covered entities to express their intent to participate in a stewardship plan by December 20, 2013. The first drug…