The Center for Drug Evaluation and Research (CDER) of the Food and Drug Administration fosters the adoption of innovative technologies by pharmaceutical companies. To assist CDER in those efforts, an ad hoc committee of the National Academies of Sciences, Engineering, and Medicine will produce a consensus report that identifies emerging and upcoming technologies (e.g., product technologies, manufacturing processes, control and testing strategies, and platform technologies) that have the potential to advance pharmaceutical quality and modernize pharmaceutical manufacturing for products regulated by CDER (small and large molecules up to monoclonal antibodies or therapeutic proteins). For the technologies for which the FDA will need to be prepared in the 5-10 years following the report, the committee will describe (1) potential pharmaceutical applications of emerging technologies, (2) key technical issues that will affect innovation, (3) regulatory issues for which the agency might want to prepare, and (4) suggestions for how to overcome those regulatory issues to facilitate the adoption of promising novel technologies in the pharmaceutical industry. The committee’s approach will include collection of information, workshops on innovation and on technical and regulatory hurdles with highlights captured in workshop proceedings, and expert analysis that culminates in a peer-reviewed consensus report. The report will describe promising innovation areas and insights on key regulatory and technical challenges that the FDA and the pharmaceutical industry will need to address to realize the benefits of the innovation.