Division of Clinical Research

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Category results for: cder

Searchable Database for Training Resources on FDA’s Updated CDER SBIA Learn Webpage

FDA’s CDER Small Business and Industry Assistance (SBIA) has revamped its CDER SBIA Learn webpage to include a comprehensive, searchable, easy-to-use database containing hundreds of training resources including recordings to webinars and conferences. This searchable database includes webinar and conference recordings from SBIA’s YouTube playlists from 2021, 2020, 2019 and 2018. SBIA also posts new conferences, webinars, and recordings on the SBIA LinkedIn page.

Progress Tracker for Medical Device Premarket Submissions: FDA Offers Soft Launch

The U.S. Food and Drug Administration (FDA) is building a secure, web-based tracker that displays the Center for Devices and Radiological Health’s progress on medical device submissions focused on premarket review. The progress tracker is the first feature of a larger platform to help us collaborate with the medical device industry. The submission’s Official Correspondent […]

Diversity in Clinical Trials: Learn about Enrollment Trends and Resources from FDA

Join the CDER Small Business and Industry Assistance webinar Diversity in Clinical Trials: Learn about Enrollment Trends and Resources from FDA December 16, 2020 | 1:00 – 2:30 p.m. Eastern FREE Registration In this era of globalization, meeting various regulatory authorities’ expectations in recruitment of diverse trial population is challenging. The need for faster drug […]

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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