Advancing Generic Drug Development: Translating Science to Approval

The purpose of the public workshop is to 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. 

This workshop is part of the SBIA Regulatory Education for Industry (REdI) series and is being offered as part of FDA’s Drug Competition Action Plan, which aims to increase competition and make it easier and more efficient for drug developers to bring more generics into the marketplace, while maintaining FDA’s high standards for quality and scientific rigor.

Topics 

Sessions and topics will be divided across different product types and key topics present in today’s environment.  
Sessions will cover the following products and topics:

• 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

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.  

Continuing Education

Real-time attendance is required for the certificate of attendance which can be used in support of CEs for the following professional organizations. Certificates are only available during the two weeks post-event.
This course has been:

• pre-approved by RAPS as eligible for a maximum of 12 credits for a two day event (appropriate to real-time attendance) towards a participant’s RAC recertification upon full completion.

• pre-approved by SOCRA who accepts documentation of candidate participation in continuing education programs for re-certification if the program is applicable to clinical research regulations, operations or management, or to the candidate's clinical research therapeutic area.

• pre-approved by SQA as eligible for 1 non-GCP or non-GLP unit for every 1 hour of instructional time towards a participant’s RQAP re-registration.

• approved by ACRP for continuing education in clinical research. ACRP will provide 1 ACRP contact hour for every 45-60 minutes of qualified material.

Technical Information

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FDA Resources

• Generic Drugs

• Generic Drug Science & Research

• Generic Drug Development

• Product-Specific Guidances for Generic Drug Development