By David B. Clissold & Ricardo Carvajal – An importer and distributor of cigars has sued FDA to enjoin the agency from taking any adverse action with respect to Djarum brand…

…all other regulatory requirements is that review of the applications may no longer be stalled by delayed pre-approval inspections, although it seems like inspections in China are still lagging due…

…2024. The memorandum is part of CMS’s efforts to engage with the public on the implementation of the Negotiation Program. These efforts also include national stakeholder calls, quarterly strategic meetings,…

…the purchaser on the original form, maintain the original form and send a copy to DEA.  The purchaser must record on its copy of the DEA-222 the number of commercial…

…and civil trial litigation and investigations under the Food, Drug, and Cosmetic Act, Federal Trade Commission Act, Consumer Product Safety Act, and Federal data privacy laws. He also held leading…

…further proceedings in the case. Why this Case Matters This case demonstrates that a court can consider a provider’s actions taken in response to public FDA safety notices when determining…

…the government’s investigation of individuals), she warned “undue or intentional delay in producing information or documents—particularly those that show individual culpability—will result in the reduction or denial of cooperation credit”…

…“Laboratory supply,” as defined by the MCA, is “a listed chemical or any chemical, substance, or item on a special surveillance list published by the Attorney General, which contains chemicals,…

…and that are packaged in a single-dose container or single-use package. An example of such a drug is a single-use vial of an injectable cancer drug that is dosed based…

…longer than a product that was approved 8 years ago. Given that patent life can also extend beyond 16 years on the biosimilar side, several products may never be eligible…

…few years. As faithful readers of our blog know, FDA’s broad interpretations of its governing statute have not always fared that well in the courts. In each of three cases—Genus…

…and 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…

…In January of this year, the petitioners submitted a supplement to the original petition with additional research on the public health impact of menthol in cigarettes. The petitioners also filed…

…Cincinnati and its law school, after service in the U.S. Army, Jim began his legal career in 1965 as a Trial Attorney with the Office of General Counsel, Food and…

…medical purpose by an individual practitioner acting in the usual course of [their] professional practice.” 21 C.F.R. § 1306.04(a). The person who knowingly fills such prescription is subject to administrative,…