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…of Appeals for the D.C. Circuit (see our previous posts here and here). Following several extensions for filing its opening brief, on August 14, 2013, POM Wonderful LLC Roll Global,…
…requirements must be met: It is created or modified to comply with the order of a physician or dentist. In order to comply, the device necessarily deviates from an otherwise…
…posts here, here, and here), so we wouldn’t be surprised if there’s a lawsuit against FDA coming down the pike. As we previously reported on the Eisai petition, Eisai asked…
…the CSA to identify products containing anabolic steroids. It is now unlawful to import, export, manufacture, distribute, dispense, or possess with intent to manufacture, distribute, or dispense an anabolic steroid…
…our previous post here), FDA proposes “to require a 505(b)(2) applicant to identify a pharmaceutically equivalent product, if already approved, as a listed drug relied upon, and comply with applicable…
…use, if [FDA] determines that— (i) the burden of creating a single, shared system outweighs the benefit of a single, system, taking into consideration the impact on health care providers,…
…in order to address the growing problem of drug shortages. In her statement before the Senate Committee on Health, Education, Labor, and Pensions, GAO Director of Health Marcia Crosse stated…
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…
…in December 2007, but is covered by a period of pediatric exclusivity scheduled to expire on June 29, 2008. Since the April 11, 2008 order, companies with a stake in…
…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…
As we previously reported, the Made in the USA claim, as a voluntary claim on consumer goods, including products under FDA jurisdiction such as foods, over-the-counter drugs, and cosmetics, continues…
…Antitrust Division’s Criminal Program. On April, 24, 2020, DOJ indicted the first person under the Executive order alleging the hoarding of face masks, face shields, surgical gowns, and disinfecting products…
…for an individually identified patient. Section 503A has always permitted compounders to compound copies of shortage medications (which are not, by definition, “essential copies” of commercially available drug products). Never…
…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…
…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…