sábado, 24 de marzo de 2012

Drug Information Update - FDA Webinar: New Draft Guidance on Safety Data Collection

Drugs > Webinars
FDA Division of Drug Information: Know the Moment It Happens

On March 27, 2012, at 11.00 a.m., FDA will present a webinar on a new draft guidance entitled "Determining the extent of safety data collection needed in late stage premarket and postapproval clinical investigations." The docket number is FDA-2012-D-0096.  

To access the draft guidance, visit http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM291158.pdf
Information about the draft guidance and webinar can be found at http://www.fda.gov/Drugs/ucm273272.htm  

This webinar will provide an opportunity to learn about the guidance from individuals involved in its preparation. It is also intended to encourage the submission of questions or comments while the guidance is still in draft form.
The guidance addresses the circumstances in which it may be acceptable to acquire a reduced amount of safety information during clinical trials. FDA webinar participants will include Dr. Robert Temple, Dr. Mary Ross Southworth, and Dr. Amna Ibrahim.

Questions may be submitted online during the webinar and will be addressed as time permits. All questions should also be submitted to docket so that they can be formally processed by FDA. 

Guidance Webinar Online-Access Instructions:
To access this webinar, follow the link provided below. Audio will broadcast from your computer speakers.
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. If you experience technical difficulties email Jeffery.Rexrode@fda.hhs.gov for assistance. Closed captioning will be provided.

Questions/Comments can be submitted live via a Q/A chat window. 

Access link: https://collaboration.fda.gov/guidancewebinars/
If you have never attended a Connect Pro meeting before, please test your connection before the lecture by following this link: https://collaboration.fda.gov/common/help/en/support/meeting_test.htm

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