By Karla L. Palmer – On Tuesday, March 15, 2016, HHS Secretary Burwell testified before the House Education and the Workforce Committee, during which Representative Buddy Carter (R. Ga.), who…

…website a final guidance document (see our previous post here) reinterpreting the statutory NCE exclusivity provisions to award NCE exclusivity for a newly approved Fixed-Dose Combination (“FDC”) drug product containing…

…and Original Equipment Manufacturers; Request for Comments” (March 2016 notification).  This notification announces the establishment of a docket to receive comments “concerning the service, maintenance, refurbishment, and alteration of medical devices,…

…one company.  When we contacted FDA on this issue in 2009, a senior FDA official acknowledged the error but also expressed his opinion that FDA was not likely to fix…

…documentation (written communications/company records) is critical to the success of any company, most especially any doing business in a regulated industry. Documents speak for the company and the writer. Documents…

…patent (ANDA 205067), filed a Complaint for Declaratory Judgment (after some previous patent infringement court proceeding) and obtained a Final Judgment on August 28, 2015 that the company’s proposed Propofol…

…No. 202834), and UCB’s VIMPAT (lacosamide) Tablets (NDA No. 022253) before the drugs were scheduled by the Drug Enforcement Administration under the Controlled Substances Act (“CSA”), and thus, before commercial…

…cooperation between the US and the EU in their oversight of traditional generic drugs.  In a joint letter to the European Commission’s Trade Commissioner and the US Trade Representative, GPhA…

…years will be to “strengthen the clinical trials enterprise,” “strike the right balance between premarket and postmarket data collection,” and “provide excellent customer service.” Clinical Trials Enterprise The key component…

…patently false and is designed to justify rulemaking and enforcement activity to effectively shut down pharmaceutical companies from communicating with consumers. FDA is taking action to effectively ban DTC broadcast…

…Strategies (“REMS”), which were created under the 2007 FDA Amendments Act.  The FDLI conference, for which Ms. Torrente also served on the planning committee, is titled “Issues and Answers: Advancing…

…would enable third parties to notify the company of a serious adverse event.  In an accompanying press release,  FDA “encourages healthcare providers to report to FDA any adverse events in…

…be used in the labeling are moot.”  FDA never finalized the draft guidance, and, in fact, removed the draft guidance from its website after receiving adverse comments.  We understand that…

…FDA opened this docket in response to a Citizen Petition filed by several pharmaceutical companies requesting that FDA clarify its policies regarding communications related to off-label uses and pre-approval communications…

…combat the diversion of legal controlled substances and listed chemicals.  As the title suggests, “DEA has Enhanced Efforts to Combat Diversion, But Could Better Assess and Report Program Results,” the…