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The Division of Drug Information (DDI) is CDER's focal point for public inquiries. We serve the public by providing information on human drug products and drug product regulation by FDA.
On Monday, April 20, 2015, from 1:00 p.m. – 2:00 p.m. EDT, the Office of Medical Policy (OMP) in FDA’s Center for Drug Evaluation and Research (CDER) will present a webinar on the draft guidance for industry, Use of an Electronic Informed Consent in Clinical Investigations: Questions and Answers.
The purpose of this guidance is to provide recommendations for clinical investigators, sponsors, and institutional review boards (IRBs) on the use of electronic media and processes to obtain informed consent for FDA-regulated clinical investigations of medical products, including human drug and biological products, medical devices, and combinations thereof.
Documents:
- Draft Guidance: Use of an Electronic Informed Consent in Clinical Investigations Questions and Answers
- Federal Register Notice (FRN)
Date of Federal Register Publication: 03/09/2015
Date Comment Period Closes: 05/08/2015
Docket Number: Docket No. FDA- 2015-05377
Webinar Speakers:
Leonard V. Sacks, M.D.
Associate Director for Clinical Methodology
OMP/CDER/FDA
and
Cheryl A. Grandinetti, Pharm.D.
Health Scientist Policy Analyst
OMP/CDER/FDA
Webinar Online-Access Instructions: To access this webinar, follow the link provided below. Audio will broadcast from your computer speakers.
Webinar access link: https://collaboration.fda.gov/
After following the link, enter as a guest and provide your FULL NAME and organization (i.e. "John Smith - FDA/CBER"). The host will then allow you to enter. Closed captioning will be provided.
Questions/Comments can be submitted live via a Q/A chat window.
Please note: There is a user capacity limit for this webinar. For those who cannot enter the webinar, please know that it will be recorded and a link will be posted to this page within one business day.
Information on fda.gov: FDA webinar April 20
FDA’s Guidance Webinar Series: http://www.fda.gov/Training/
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