Home

Save the Dates for 2026 FDA-CRCG Workshops

2026 FDA–CRCG Events

  • May 5–6: BE Innovations for Oral Generic Products
    Biowaivers, Bridging, and Generic Development for Oncology and Discontinued Products
  • September 23–24: Navigating the GLP‑1 Generic Pathway
    From Peptide to Patient
  • October 14–15: Advancing Bioequivalence Frameworks for Inhalation and Nasal Drug Products
    Optimizing In Vitro, In Vivo, and In Silico Methods
  • December 1–2: Long‑Acting Injectable Generics
    Navigating Technical Hurdles in Product Development and Regulatory Assessment

Upcoming and Past Events and Workshops

Check out our upcoming and past events and workshops.

Research Projects

Learn more about ongoing and past research projects sponsored by the Center for Research on Complex Generics.

The Center for Research on Complex Generics (CRCG) facilitates research and collaborations across industry, academia and the FDA to increase access to safe and effective generic drugs.

  • DRIVING INNOVATION

    CRCG promotes generic industry training and engages the public in complex generics research. Researchers work collaboratively to conduct studies and develop new techniques in complex generics.

  • AREAS OF EXPERTISE

    Faculty conduct drug development research that spans many fields, including complex injectables, drug-device combination products, locally-acting drugs, and quantitative clinical pharmacology.

  • RESEARCH CAPABILITIES

    The University of Maryland, Baltimore and University of Michigan are well-positioned to conduct complex generic drug research that spans from formulation and analytical characterization to clinical studies.

Events

Education & Training

GDUFA Research Outcomes

Search or browse the

Discover
Headshot of David Gaugh

David R. Gaugh, R.Ph.
Interim President and CEO,
Association for Accessible
Medicines (AAM)

Access to high quality, safe, effective, and affordable generic medicines remains a significant public health priority. The role that the CRCG plays in fostering collaboration between FDA, industry, academia, and other key stakeholders through its education, training, research, and other activities directly helps the generic industry to address scientific challenges and accelerates the development of generic products, including complex generics. AAM is excited to continue its collaboration with CRCG to ensure more generic medicines are being developed and made accessible to patients and healthcare systems who need them.