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…“Software verification, validation, and hazard analysis must be performed for any software components of the device.” This high level statement leaves many questions about details. However, far too often, potential…
…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,…
…offer advice about which customers to ship to, DEA could, for example, provide guidance around best practices in developing suspicious orders monitoring systems. Industry would likely welcome such guidance, so…
…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…
…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…
…25, 2012, November 11, 2019, and August 26, 2019, respectively, but are each subject to a 6-month period of pediatric exclusivity.) Impax’s Complaint requests that the court rule that the…
…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…
…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…
…as a Class II device. On March 30, 2011, FDA rescinded this clearance. Last week, ReGen filed suit based upon the theory that FDA lacks authority under the Food, Drug,…
…responsible party (in the case of domestic facilities) or the importer. Again, the hours could add up quickly, considering the time spent on audit checks, inspections, and monitoring of disposition,…
…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…
…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…
…issued to the public, the agency shall… [i]dentify for the public, in a complete, clear, and simple manner, the substantive changes between the draft submitted to OIRA for review and…
…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…