martes, 30 de julio de 2013

CDER Small Business Update

The Information Source for Regulated Domestic and International Small Pharmaceutical Business
FDA/CDER's Small Business Assistance

On August 5, 2013, from 10:00 AM - 11:00 AM (EDT), FDA will present a webinar on a new draft guidance entitled "Draft Guidance For Industry On Expedited Programs For Serious Conditions Drugs And Biologics."
The 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.

Questions may be submitted to docket (see Federal Register (FR) Notice) so that they can be formally processed by FDA.

Online-Access Instructions for Webinar: 
. After following the link, enter as a guest and provide your FULL NAME and organization (i.e. "John Smith - FDA/CDER"). The host will then allow you to enter.
. Audio will broadcast from your computer speakers.
. Closed captioning will be provided.
. Questions/Comments can be submitted live via a Q/A chat window.

. If you experience technical difficulties, email for assistance.

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