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Tag: FDA webinar

Webinar Materials: Final Guidances on Safety and Performance Based Pathway Criteria for Certain Device Types

On September 24, 2020, the U.S. Food and Drug Administration (FDA) hosted a webinar for industry and other stakeholders interested in learning more about two final guidance documents that provide performance criteria for the following device types in support of the Safety and Performance Based Pathway:  Conventional Foley Catheters Cutaneous Electrodes for Recording Purposes  You […]

FDA OMHHE’s Clinical Trial Diversity free webinar

Tuesday, September 22 from 1:00 – 2:00 p.m. The FDA Office of Minority Health and Health Equity (OMHHE) at the U.S. Food and Drug Administration (FDA) presents a webinar featuring Drs. Barbara E. Bierer (Faculty Director, MRCT Center; Professor of Medicine, Harvard Medical School) and Luther T. Clark (Deputy Chief Patient Officer, Merck). Drs. Bierer […]

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 […]

Webinar on FDA’s Regulation of Face Masks and Surgical Masks During the COVID-19 Pandemic

On Tuesday, August 4, 12:00 p.m.-1:00 p.m. ET, the U.S. Food and Drug Administration (FDA) will host a webinar on the FDA’s regulation of face masks and surgical masks during the COVID-19 pandemic. This webinar will expand the scope of the respirator webinar series to discuss face masks and surgical masks. During this webinar, representatives […]

August Dates Announced for the FDA’s Virtual Town Hall for Labs and Manufacturers on Coronavirus (COVID-19) Diagnostic Tests

In August, the U.S. Food and Drug Administration (FDA) will continue hosting virtual Town Halls for clinical laboratories and commercial manufacturers that are developing or have developed diagnostic tests for SARS-CoV-2 on the following dates: August 5, 2020 from 12:15 pm – 1:15 pm Eastern Time August 12, 2020 from 12:15 pm – 1:15 pm […]

Free Food and Drug Administration 1-hr “Home Study” CME/AAPA/CNE/CPE/CPT/CPH Webinars – Drug Information Update

3D Printing in Drug Development and Emerging Health Care Research Funding Opportunities to Reduce Preventable Harm Other New “Home Study” CE Webinars available: FDA’s Bad Ad Program Nitrosamine Impurities in Drugs: What Health Care Professionals Need to Know FDA Regulation of Color Additives in Drug Products FDA Oncology Center of Excellence’s Project Facilitate: An Overview […]

Learning Library Now Available on FDA’s YouTube Channel

FDA’s CDER Small Business and Industry Assistance (SBIA) is making hundreds of recordings available via a YouTube learning library.Bookmark and share 2020, 2019, 2018, and 2017 recordings of webinar and conference presentations. New content will be posted on SBIA’s LinkedIn page. These subject matter expert presentations are intended to educate and help industry navigate FDA policies and procedures. To earn free […]

FDA Webinar: Free 1-hr “Live” CME/ AAPA/ CNE/ CPE/ CPT/ CPH Webinar on CURE ID – Drug Information Update

June 9, 2020 from 1:00 p.m. – 2:00 p.m. FDA Drug Topics: CURE ID: Capturing Clinician’s Experiences Repurposing Drugs to Inform Future Studies in the Era of COVID-19, presented by Heather Stone, MPH, Health Science Policy Analyst in FDA’s, Center for Drug Evaluation and Research, Office of Medical Policy. To register for the online meeting, please […]

FDA webinar: CDER’s NextGen Portal

Still submitting paper to CDER? Send electronically with CDER’s NextGen Portal instead! (for submissions not required in eCTD) This webinar provides an overview of CDER’s NextGen Portal for those in industry who are currently not required to submit in eCTD and are sending information to CDER in paper. CDER’s NextGen Portal is designed to allow a sponsor […]

SAVE THE DATE: 2020 Public Training Courses, Workshops, and Meetings

January 28-30, 2020: ASM Biothreats (Arlington, VA) – Hosted by the American Society for Microbiology, to offer professionals in biodefense, biosecurity, and biological threats the opportunity to exchange knowledge and ideas, and explore the latest developments and emerging technologies. (fee) January 28-29, 2020: HHS Tick-Borne Disease Working Group public meeting (Washington, DC and webcast) – The Working Group will 1) […]

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