Food and Drug Administration (FDA)

FDA Comment Deadline: Standards for Future Opioid Analgesic Approvals and Incentives for New Therapeutics To Treat Pain and Addiction

The Food and Drug Administration (FDA) seeks public comments to accompany its September 17, 2019 public hearing entitled “Standards for Future Opioid Analgesic Approvals and Incentives for New Therapeutics to Treat Pain and Addiction.” The hearing relates to the draft guidance on the application of FDA's existing benefit-risk assessment framework to applications for approval of opioid analgesic drugs.

This public hearing is intended to receive stakeholder input on the approval process for new opioids and how FDA might best consider the existing armamentarium of therapies, among other factors, in reviewing applications for new opioids to treat pain. FDA also seeks input on potential new preapproval incentives aimed at fostering the development of new therapeutics to treat pain, as well as new treatments for addiction.

Members of the public may submit comments online at Regulations.gov, or via mail. More information is available at this Federal Register notice.

FDA Comment Deadline: Center for Tobacco Products, Funded Trainee/Scholar Survey

The Food and Drug Administration (FDA) seeks comments on a proposed data collection regarding the FDA's Center for Tobacco Products (CTP)'s Funded Trainee/Scholar Survey.

FDA's CTP and the National Institutes of Health maintain an interagency partnership to foster the development of the emerging field of tobacco regulatory science (TRS). This study will use the CTP, FDA Funded Trainee/Scholar Survey to gather data on the characteristics, activities, and impact of training programs funded by the CTP and other partners. This evaluation will also determine how CTP-funded research and associated training programs and activities increase knowledge and skills related to TRS and interest to pursue careers in a TRS-related field. This survey provides support to determine the extent to which programs and activities generate positive impacts to increase the number of researchers who focus on TRS and TRS-related topics, specifically within CTP's priority domains. The survey builds upon previous evaluations of trainees and training activities and provides necessary evidence to inform FDA decision making. The web survey will gather responses from Tobacco Centers of Regulatory Science (TCORS) trainees and other CTP-funded trainees and scholars. Results will provide insights and directions to support future training and funding investments.

FDA CTP will use findings from this study to determine whether its TRS training support investments lead to meaningful change that supports CTP aims, and to inform decisions about potential future investments. CTP's training support intends to build additional capacity for TRS that establishes an evidence base related to CTP's research priorities so that FDA regulations, communications, and application review are founded on rigorous, relevant scientific study.

Respondents include current and former TCORS or other CTP-funded trainees and trainee principal investigators (PIs) or training directors. PIs and training directors will be asked to provide trainee names and email addresses and encourage trainees to participate in the survey. Current and former trainees will be asked to read an informed consent and take a brief web-based survey.

Members of the public may submit comments online at Regulations.gov, or by mail. More information is available at this Federal Register notice.