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Tag: cder

CDER SBIA Regulatory Education for Industry (REdI) Annual Conference

August 25-28, 2020 This workshop is free of cost. Register here. Interact with and learn directly from FDA’s regulatory experts in drugs and medical devices. This course is designed to provide participants with a strong, basic foundation in understanding the FDA’s drug and medical device regulatory requirements. Presentations include Q&A sessions. Please select the track […]

FDA CDER Meetings, Conferences, and Workshops: December 2019

Public Meeting on CDER Standard Core Sets Clinical Outcome Assessments and Endpoints Grant Program; Dec. 5; Silver Spring MD; Live webcast available Repurposing Off-Patent Drugs: Research & Regulatory Challenges; Dec. 5-6; Rockville MD Public Workshop on Patient-Focused Drug Development: Guidance 4 – Incorporating Clinical Outcome Assessments into Endpoints for Regulatory Decision Making; Dec. 6; Silver […]

FDA CDER Meetings, Conferences, and Workshops: October-November 2019

October 2019 PQRI BTC 2019 Webinar Series: Holistic QbD to Enable Product Quality; Oct. 10 @ 10:30 am EDT SBIA Webinar: Electronic Submission of Adverse Event Reports to FDA Adverse Event Reporting System (FAERS) using International Council for Harmonisation (ICH) E2B(R3) Standards; Oct.11 @ 1 pm EDT Antimicrobial Drugs Advisory Committee Meeting; Oct 16; Silver […]

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