# Center for Research on Complex Generics

> **NIH FDA U18** · UNIVERSITY OF MARYLAND BALTIMORE · 2022 · $1,000,000

## Abstract

Project Summary:
We propose a Center for Research on Complex Generics (CRCG), which will serve the public by working with
the Food and Drug Administration (FDA) and the generic drug industry to identify and organize activities that
promote the development of complex generics, including greater first cycle approvals. CRCG will be a science-
based resource that adds to ongoing FDA Office of Generic Drugs (OGD) activities, with a focus on complex
generics and opportunity to learn about, and contribute to, complex generic drug development. This viewpoint
reflects the perspective that pre-competitive spaces in drug development science, including complex
formulation science, are public spaces that require active public involvement. We will work with the best
content experts to move pharmaceutical development science for more accessible medicines forward. The
mission of the CRCG is to support the FDA's efforts to enhance research collaborations with the generic
industry to further the FDA's mission of increasing access to safe and effective generic drugs. This mission will
be pursued through collaborative research, training, and exchange. Stakeholders include FDA, the generic
industry, and all others with an interest in better pharmaceutical development science for more accessible
medicines. Activities include webinars, workshops, pilot laboratory projects to meet technique development
needs, laboratory demonstrations, a Visiting Scientist Program, as well as a Complex Generics Scholars
program and student events. The sum of these activities describe a vibrant, cutting edge Center that stimulates
innovative thought, disseminates understanding of complex drugs and practices, and generates new
knowledge in support of the FDA's fundamental mission – to promote and protect the public health.

## Key facts

- **NIH application ID:** 10470002
- **Project number:** 5U18FD007054-03
- **Recipient organization:** UNIVERSITY OF MARYLAND BALTIMORE
- **Principal Investigator:** JAMES E POLLI
- **Activity code:** U18 (R01, R21, SBIR, etc.)
- **Funding institute:** FDA
- **Fiscal year:** 2022
- **Award amount:** $1,000,000
- **Award type:** 5
- **Project period:** 2020-08-01 → 2025-07-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10470002

## Citation

> US National Institutes of Health, RePORTER application 10470002, Center for Research on Complex Generics (5U18FD007054-03). Retrieved via AI Analytics 2026-05-24 from https://api.ai-analytics.org/grant/nih/10470002. Licensed CC0.

---

*[NIH grants dataset](/datasets/nih-grants) · CC0 1.0*