Latest Federal Register Notices
20 Drug Determinations on ANDA Availability
Federal Register notice: FDA has determined that 20 drug products (detailed below) were not withdrawn from sale for reasons of safety or effectiveness. The determination means that the agency will continue to approve ANDAs that refer to the products as long as they meet relevant legal and regulatory requirements. To view the 1/15 notice, click here.
Bulk Drug Substance Listing Reopened for Comments
Federal Register notice: FDA has reopened the comment period for a notice that appeared in the 7/31/2020 Federal Register in which FDA identified certain bulk drug substances (active pharmaceutical ingredients) that it has considered and proposes to include or not include on the list of bulk drug substances for which there is a clinical need. To view the 1/15 notice, click here.
Info Collection on FDA Recall Regulations
Federal Register notice: FDA is seeking comments on an information collection extension entitled “FDA Recall Regulations — 21 CFR Part 7” (OMB Control Number 0910-0249). The collection helps support implementation of Section 701 of the Federal Food, Drug, and Cosmetic Act (21 USC 371) pertaining to product recalls, and regulations in part 7 (21 CFR part 7), subpart C promulgated to clarify and explain associated practices and procedures. To view the 1/14 notice, click here.
FDA Seeks Advisory Committee Consumer Reps
Federal Register notice: FDA is requesting that any consumer organizations interested in participating in the selection of voting and nonvoting consumer representatives to serve on its advisory committees or panels notify FDA in writing. FDA is also requesting nominations for voting and nonvoting consumer representatives to serve on advisory committees and panels for which vacancies currently exist or are expected to occur in the near future. To view the 1/3 notice, click here.
FDA Debars Insys Sales Manager
Federal Register notice: FDA has issued an order to permanently debar former Insys Therapeutics regional sales manager Joseph A. Rowan from providing services in any capacity to a person that has an approved or pending drug product application. Last year, he was convicted of engaging in a conspiracy whereby Insys employees bribed and provided kickbacks to medical practitioners in various states to get those practitioners to increase prescribing Subsys (fentanyl) to their patients. To view the 1/3 notice, click here.
Insys Therapeutics Sales Manager Debarred
Federal Register notice: FDA has issued an order to permanently debar former Insys Therapeutics regional sales manager Sunrise Lee from providing services in any capacity to a person that has an approved or pending drug product application. Last year, she was convicted of engaging in a conspiracy whereby Insys employees bribed and provided kickbacks to medical practitioners in various states to get those practitioners to increase prescribing Subsys (fentanyl) to their patients. To view the 1/12 notice, click here.
Guide on Device Safer Technologies Program
Federal Register notice: FDA has made available a final guidance entitled Safer Technologies Program for Medical Devices. The document describes a new, voluntary program for certain medical devices and device-led combination products that are reasonably expected to significantly improve the safety of currently available treatments or diagnostics that target an underlying disease or condition associated with morbidities and mortalities less serious than those eligible for the Breakthrough Devices Program. Such products are eligible for the program if they are subject to review under a PMA, De Novo classification request, or 510(k). To view the 1/11 notice, click here.