| This virtual public workshop will communicate how outcomes from FDA research conducted under the Generic Drug User Fee Amendments (GDUFA) guide and facilitate generic drug development, regulatory assessment, and approval. The workshop will focus on common issues seen in Abbreviated New Drug Applications (ANDAs), link GDUFA science and research on complex products and scientific issues to product-specific guidance development and pre-ANDA meeting discussions, and examine various areas of the science and cutting-edge methodologies behind generic drug development. Learning Objectives - Apply various mechanisms and processes that industry can use to obtain advice from FDA to facilitate generic drug development.
- Comprehend new developments in science, guidance, and review experience for specific types of generic drug products.
Intended Audience
Scientists, researchers and regulatory affairs professionals who work on or are interested in working on the development of generic drugs including complex generic products that are more challenging to develop. | | Topics Covered - COVID-19 Impact on Generic Drug Regulation and Evaluation
- Assessing Generic Drug Products of Oral Dosage Forms
- Complex Generics: Complex Injectables, Ophthalmic and Otic Products
- Cutting-Edge Science in Complex Generics
- Complex Generics: Nasal and Inhalation Products
- Complex Generics: Topical Products
This workshop is part of the SBIA Regulatory Education for Industry (REdI) series. | |
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