…who rely on international and local standards to fill prescriptions for patients,“ and different INNs “may impede access to the annual $20 billion savings—in just the U.S. alone—that biosimilars have…

…of the conference program can be obtained here.  Hyman, Phelps & McNamara, P.C.’s Douglas B. Farquhar will be presenting at the conference in a session titled “International Inspections: Preparing For…

…FDA Regulation of Pharmaceutical Controlled Substances.”  The conference will include presentations from other regulatory and legal experts on myriad topics, including presentations from key government officials, such as Drug Enforcement…

…in relying on FDA’s Citizen Petition procedures as an “alternative administrative mechanism” that bars FCA actions. The brief also argued that failure to report adverse events to FDA can theoretically…

…clinical trial” must submit to the National Institutes of Health certain required information for inclusion in the clinical trial data bank at ClinicalTrials.gov.  Currently, only descriptive information about the trial…

…regulations, including administrative, civil and criminal sanctions.  DEA registration, recordkeeping and reporting, labeling and packaging, importation and exportation, security and disposal requirements for handlers of prostanozol and methasterone take effect…

…here (Robert Perlstein, M.D.), and here (Special Agent Alex Davis).   In its testimony, FDA asked the Commission to alter the Guidelines by declaring that for criminal offenses involving any…

…of America. Before that, she practiced antitrust law as Counsel at O’Melveny & Myers LLP where she focused on antitrust litigation, civil and criminal investigations, and federal and state class…

…and sales made at a nominal price. This reporting requirement goes into effect for calendar quarters beginning January 1, 2022. The information is to be reported in a time and…

…that the manufacturing exceeded minimal processing” compatible with that claim. The panel held out the possibility that a qualified use of “natural” might be supportable. Gluten Free Alcoholic Beverages: TTB…

A determination of “intended use” is fundamental to the U.S. Food and Drug Administration’s (FDA) regulation of drugs and medical devices under the Federal Food, Drug, and Cosmetic Act (FDCA)….

…all registrants. For example, if a Registrant A sold a total of 100,000 MMEs in New York in one year and all registrants sold a total of 10,000,000 MMEs, Registrant…

…States are consistently inconsistent as to what triggers licensing requirements. Failure to obtain and maintain required licenses can result in substantial civil financial penalties and administrative sanctions, including denial, suspension…

…a violation of a rule under 15 U.S.C. 57a, allowing the FTC to seek not only an injunction but also civil penalties. In fall of 2019, the FTC held a…

…to contribute in substantive ways to sophisticated, high-end matters. Strong verbal and writing skills are required. The ideal candidate will have experience working at FDA, DOJ, or DEA, prior big…