Last 23 June 2021, FDA hosted a workshop to discuss Research Priorities and Generic Drug Science.
James Polli, PhD, and Anna Schwendeman, PhD, co-directors, Center for Research on Complex
Generics (CRCG), presented generic industry perspectives via summaries from a survey as well as
interviews. The CRCG’s mission, they said, is “to increase access to safe and effective generic drugs
through enhanced infrastructure/communication, education, and research collaboration across industry, academia, and the FDA.” The center does this through communication, education, and research initiatives. It hosts a complex generic scholars program, hands-on laboratory demonstrations, student-centered events, workshops, and webinars, and also does general public outreach. The CRCG has planned public online-only workshops through the end of 2021.
The CRCG also plans to address industry concerns about working to address concerns about leachables and extractables (L&E) reviews, working on the development of analytical characterization methods and risk assessment for N-nitrosodimethylamines (NDMAs) [see Guidance for Industry: Control of Nitrosamine Impurities in Human Drugs (Revision 1), February-2021 (IDRAC 327456)], and organizing workshops on specific complex products and newly developed regulatory guidances to provide clarifications and to solicit industry feedback. In addition, the CRCG aims to work on projections concerning potential scientific questions for products with patent expirations in 5-10 years.