Regulatory Roundup: FDA, Arkansas Sign Agreement to Enhance Regulatory Science

FDA released this week a new final guidance for industry, Residual Drug in Transdermal and Related Drug Delivery Systems. The document provides recommendations “to developers and manufacturers of transdermal drug delivery systems (TDDS), transmucosal drug delivery systems (TMDS), and topical patch products regarding use of an appropriate scientific approach during product design and development-as well as during manufacturing and product lifecycle management-to ensure that the amount of residual drug substance at the end of the labeled use period is minimized.” Because these types of products purposely contain more drug substance than is intended to be delivered to the patient in order to facilitate the medication’s delivery, formulators and manufacturers must use a scientific-based approach to ensure the product’s quality, efficacy, and safety. Specifically, the approach should “ensure that the amount of residual drug substance is minimized consistent with the current state of technology,” says the guidance. The document provides information on achieving this minimization and suggests applying a QbD approach.

FDA has signed an agreement with the state of Arkansas to create a joint center to enhance regulatory science. The memorandum of understanding is part of the agency’s National Center for Toxicological Research (NCTR) and is the first agreement of its kind with NCTR. The framework calls for joint research, educational training, collaborations, and outreach, according to an agency press release. In addition, a joint committee will be formed to help manage the arrangement. NCTR is based in Jefferson, Arkansas, and conducts peer-reviewed research, provides training, and develops novel scientific tools to aid the agency in regulatory decision-making process, according to the announcement.