The Food and Drug Administration (FDA) has issued for public comment a report prepared by the Center for Drug Evaluation and Research (CDER) identifying “current priorities in regulatory science related to [CDER’s] mission.” The draft report, titled “Identifying CDER’s Science and Research Needs,” will also “guide strategic planning and internal research efforts.” Comments on related “research and initiatives that may be ongoing” and “opportunities to collaborate with external partners and stakeholders to maximize resources to address the areas for development discussed previously” should be submitted by September 26, 2011.

According to FDA, CDER grouped science and research needs into seven categories: (i) improve access to post-market data sources and explore whether they can be used in different types of analyses; (ii) “improve risk assessment and management strategies to reinforce the safe use of drugs”; (iii) evaluate whether various regulatory communications are effective, (iv) “evaluate the links among product quality attributes, manufacturing processes, and product performance”; (v) “develop and improve predictive models of safety and efficacy in humans”; (vi) make improvements to clinical trials; and (vii) individualize patient treatment. See Federal Register, July 26, 2011.