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  • FDA CDER SBIA Events – Supporting US FDA Small Business Industry . . .
    Supporting the events of US FDA - CDER - Small Business Industry Assistance Powered by Concerted Solutions, Inc
  • SBIA Webinars Launch Page – FDA CDER SBIA Events
    FDA CDER SBIA Events This launch page contains the information for the NEXT upcoming SBIA webinar Each future webinar will be placed on this page in turn
  • Past Events – FDA CDER SBIA Events
    View all Past SBIA Events on FDA gov 2025 December 11, 2025: Quality and Regulatory Predictability: Shaping USP Standards May 20, 2025: OTC Monograph Drug User Fee Program (OMUFA): Understanding FY 2025 User Fees and Registration May 8, 2025: FDA CDER Overview: Certificates of Confidentiality
  • Generic Drugs Forum 2026 – FDA CDER SBIA Events
    Generic Drugs Forum (GDF) 2026: April 22-23, 2026 View Start Time on World Clock This is a NO COST event FDA Headquarters – White Oak, Maryland or attend Virtually Online The annual Generic Drugs Forum is a two-day event designed to facilitate the development and approval of safe, effective, and high-quality generic medicines This premier event brings together FDA subject matter experts
  • Frequently Asked Questions – FDA CDER SBIA Events
    Most SBIA Events currently allow for these types of Continuing Education Credits: Regulatory Affairs Professionals Society (RAPS) – FDA SBIA events are generally eligible for Regulatory Affairs Certification (RAC) professional development credits
  • FDA CDER SBIA Events
    Event Agenda The agenda is still being refined and may be updated over time The current version is v4, uploaded on August 19, 2024
  • Advancing Generic Drug Development Conference 2024 - SBIA Events
    The purpose of this public workshop is to communicate how FDA’s Generic Drug User Fee Amendments (GDUFA) Science and Research Program outcomes guide and facilitate generic drug development, regulatory assessment, and approval This workshop will focus on common issues seen in abbreviated new drug applications (ANDAs), GDUFA III updates, GDUFA science and research on complex products and
  • FDA | MHRA | HC Good Clinical Practice . . . - SBIA Events
    A Joint US-FDA | MHRA-UK | Health Canada Good Clinical Practice Pharmacovigilance Symposium February 13-15, 2024


















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