Information for industry

Information for industry FDA is extending the proposal period for the Quality Metrics Site Visit Program for Center for Drug Evaluation and Research and Center for Biologics Evaluation and Research Staff. Submissions are now due December 17, 2018. FDA launches new pilot to advance innovative clinical trial designs as part of agency’s broader program to modernize drug development and promote innovation in drugs targeted to unmet needs - Drug and biologic companies who participate in the Complex Innovative Designs Pilot Meeting Program will have additional opportunities to meet with agency staff to discuss the use of novel complex innovative trial designs (CID) for their clinical development programs. Complex innovative trial designs includes the use of seamless trial designs, modeling and simulations to assess trial operating characteristics, the use of biomarker enriched populations, complex adaptive designs, Bayesian models and other benefit-risk determinations, and other novel designs. The new program is aimed at helping to solidify the science used to support these novel approaches, and promote their adoption in drug development programs where these trial constructs can advance innovation. Sponsors may submit meeting requests for the pilot program through June 30, 2022. Reminder: Comments are due on the draft guidance for industry, Smallpox (Variola Virus) Infection: Developing Drugs for Treatment or Prevention (PDF, 120 KB) by September 10, 2018. More: MCM-Related Guidance by Date