The research studies conducted under Generic Drug User Fee Amendments (GDUFA) initiatives support development of general and product-specific guidances for industry to efficiently develop new generic products. OGD also publishes an annual research report each fiscal year, summarizing the research activities and outcomes from both extramural and intramural projects.
Notable Guidances Related to GDUFA Science and Research Projects
Recent product-specific recommendations for complex products developed as a result of regulatory science projects:
- Draft Guidance: ANDAs for Certain Highly Purified Synthetic Peptide Drug Products That Refer to Listed Drugs of rDNA Origin Guidance for Industry
- Draft Guidance: Fluorometholone ophthalmic suspension
- Draft Guidance: Assessing Adhesion with Transdermal Delivery Systems and Topical Patches for ANDAs
GDUFA Science and Research Reports
These annual reports describe the activities and progress in each of five regulatory science priority areas…