Research on Complex Generics

The Food and Drug Administration (FDA) has issued solicitation RFA-FD-27-001, a single-source funding opportunity specifically for The University of Maryland. The primary objective is to expand American access to safe, high-quality generic medicines and mitigate drug shortages by fostering a competitive, multi-sourced market. The scope of work involves identifying scientific challenges in the development of complex generic products, funding collaborative research on the regulatory review process, and creating a scalable model to translate research findings into industry best practices. The award provides one year of initial support with recommended funding for four additional years, with a total potential value reaching $12 million over the five-year period. Applications are evaluated based on scientific and technical merit, specifically scoring significance, investigator qualifications, innovation, approach, and environment. Preference is given to projects that align with the FDA's Public Health Pillars. Applications must be submitted electronically via Grants.gov by December 14, 2026, and require active registrations in SAM, eRA Commons, and the assignment of a Unique Entity Identifier.