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…an interim order banning the export of certain drugs from Canada. The Final Rule As discussed in our prior post, the Final Rule implements Section 804 of the Federal Food,…
…on for approval, but rather a different drug: COLBENEMID, a fixed-dose combination drug product containing probenecid (500 mg) and colchicine (0.5 mg) FDA approved under NDA 012383 on July 27,…
…the most favored nation price for Part D drugs where insufficient competition exits and seniors are faced with prices above those in comparable OECD countries. The CMMI model would test…
…(Triangle). FDA issued this order based on its finding that several Triangle products contained kratom that tested positive for salmonella. FDA issued the order after the company failed to respond…
…who signed the prior DEA registration is not available or has left the company. Electronic comments must be submitted, and written comments must be postmarked, on or before April 22,…
…the FTC Staff’s cross appeal. As a result, the final order is broader than the order issued by the ALJ in 2012. Specifically, the Commission concluded that: 36 (compared to…
…intensified when later on March 27, 2014 the DPH Commissioner Bartlett and the Public Health Council approved an Emergency Order stating: “No registered individual practitioner shall prescribe or order, and…
…180-day, real-time or panel track supplement to FDA; and For Health Canada, specify if it represents a new or significant change amendment Class III or IV submission to Health Canada….
Somewhat later than anticipated, the Federal Trade Commission (“FTC”) has published a revised version of its guide, .Com Disclosures. The FTC released the original guide 13 years ago, when mobile phones…
…results of the November election. The three executive orders and the possible fourth are described below. Executive Order on Importation of Drugs One Executive Order directs HHS to complete its…
…of “Made in the USA” and other U.S.-origin claims, and to consider whether it can improve its “Made in USA” enforcement program. The agenda is posted here. The comment period…
…on file from Gilead with respect to each ORDER TO SHOW CAUSE letter. And Gilead takes the PTO to town(!): As described below, Applicant believes that the Order rests on…
…and the court granted, a Motion for Clarification, Amendment, or Reconsideration of Order raising certain jurisdictional issues. FDA promptly filed a Motion to Dismiss – and a Proposed Order – arguing…
…appropriate only when there is a scientific and/or medical dispute related to a final order. A proposed order or an interim order is not an appropriate subject for an FDR….
…five Commissioners questioning the two-RCT substantiation requirement in recent FTC consent orders, suggests that we may well see fewer two RCT orders in the future. This decision is unlikely to…