Amid the ongoing shortage of local anesthetic drugs, the FDA has drafted new guidance for drugmakers, which could eventually help curb the supply issues.
The guidance is "intended to assist developers in generating the data necessary to support different indications and labeling claims for these drugs," the agency wrote.
The draft was published March 15 and will be available for comments and suggestions for 90 days. After that point, the FDA will review and consider commentary as it refines the final version of the guidance.
The draft contains nonbinding recommendations for drugmakers, including considerations of discussions to have early on in the development process, which data and features to pay close attention to throughout the process, efficacy and safety considerations as well as endpoint analysis.
"Collecting data on clinically meaningful outcomes would be highly valuable, and FDA encourages sponsors to consider collecting such data even if not intended to support a regulatory decision," the draft guidance notes. "Furthermore, using these outcomes as clinical trial endpoints could provide the basis for inclusion in the FDA approved labeling."
The guidance also suggests that "if a sponsor plans to include novel endpoints in a local anesthetic drug product development program, FDA strongly encourages the sponsor to discuss such plans with the Division early in the drug product development process."