Last fall, when AMG Capital Management, LLC v. FTC was pending before the Supreme Court, former Federal Trade Commission (FTC) Commissioner Rohit Chopra (now Director of the Consumer Financial Protection…

…deliver N95 facemasks to consumers. The company on multiple occasions failed to deliver any PPE at all, failed to deliver PPE in a timely manner, failed to issue any refunds,…

…the catch-all phrase “any other information CMS deems necessary” was deleted from this list. A misclassification also includes correctly reporting drug product information, but paying rebates at a level not…

…website.  The updated draft does not significantly alter any sections of the original Discussion Draft, but it does include several new provisions of interest – many of which appear to…

…three state plans as well as a tribal plan for editing or amendment. USDA, Status of State and Tribal Hemp Production Plans for USDA Approval (updated Apr. 29, 2020). Four…

…this fiscal year. Some other final guidance documents on this A-list include 1) cybersecurity in medical devices: quality system considerations and content of premarket submissions and 2) breakthrough devices program…

…and here. Below we discuss the transition plan for each of the types of devices. At a high level, FDA will be allowing manufacturers a period of no less than…

…many device companies in planning a clinical trial, such as having only a few study sites and small total numbers of patients enrolled in many studies, particularly for 510(k)s. If…

…self-medication as directed in proposed labeling.  Those opposed to forced switches have argued that FDA can only authorize a switch over the NDA sponsor’s objections following a formal, trial-like administrative…

…about the dilemma that FDA faces in its oversight of foods and critical medical products.  Although our government always faces financial constraints, we cannot afford to put FDA, which performs…

…including one in which 28 original data files were deleted and another in which a clock was changed prior to samples being reanalyzed. In some instances, “trial” tests were performed…

…version, would establish a process for a sponsor of a drug eligible for accelerated approval to voluntarily submit, and for FDA to agree to, an “accelerated approval development plan” for…

…need to submit plans for monitoring, identifying, and addressing post market cybersecurity vulnerabilities. Consistent with the existing premarket cybersecurity guidance, FDA recommends submitting a Cybersecurity Management Plan that should also…

…or manufacturing technologies) on safety and regulatory status. FDA cites both of the above guidance documents in its partial denial of a citizen petition submitted by the International Center for…

…cause false information about drug prices to be submitted to the plaintiff health care plans, which results in the plans reimbursing the original price of the branded prescription drug rather…