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# FDA Touts Complex Generic Drug Efforts
- URL: https://www.fdaweb.com/fda-touts-complex-generic-drug-efforts/
- Published: 2021-05-04T12:00:00.000Z
- Updated: 2026-09-14T16:57:27.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5149248

CDER Office of Generic Drugs Office of Research and Standards director **Robert Lionberger** says the agency has used GDUFA and other techniques to encourage the development of complex generic drugs. In an online [post](https://www.fda.gov/drugs/news-events-human-drugs/generic-drugs-21st-century-fdas-actions-create-transparency-and-value-complex-generic-product?ref=fdaweb.com), Lionberger reviews activities under GDUFA 1 and 2 to improve the scientific foundation for complex generics. He says the ongoing GDUFA 3 negotiations are an opportunity to build on the successes of GDUFA 1 and 2 “to invest in FDA initiatives to support complex generic development and assessment.”

The post also reviews initiatives taken by FDA outside of GDUFA for maximal use of generic drug pathways, Center for Research on Complex Generics, increased transparency, increased innovation and efficiency, and FDA’s Drug Competition Action Plan.

A Webinar later this month will give an overview of product-specific guidances and their role in facilitating generic drug development and generic drug application assessment, Lionberger says. He says the agency will continue to give constructive feedback to applicants early in product development.