martes, 12 de noviembre de 2013

CDER Small Business Webinar on ANDA Submissions – Refuse-to-receive Standards - November 18, 2013

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

CDER Small Business Webinar on Guidance for Industry: ANDA Submissions –                    
Refuse-to-receive Standards November 18, 2013

On Monday November 18, 2013, at 11am ET, the CDER Small Business Assistance Program will present a webinar entitled the Guidance for Industry: ANDA Submissions – Refuse-to-Receive Standards.

The webinar objectives:
  • Clarify implementation dates (what is current policy and when future policy will be implemented)
  • Highlight specific points/topics covered by the draft RTR guidance
  • Clarify points in the draft guidance that have raised concerns/questions via Docket comments and feedback from a similar presentation delivered at the 2013 Generic Pharmaceutical Association Fall Technical Conference (Oct. 28-30, 2013)
  • Answer further questions provoked by the draft guidance
To register for this Event, please go the following link:
(Registration password needs to be 8 characters and alphanumeric)

Guidance Webinar Online - Access Instructions (there is no call in access):

To access this webinar, follow the presentation 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 for assistance. Closed captioning will be provided.
Questions/Comments can be submitted live via a Q/A chat window.

To view presentation:
After you register, to access this webinar, please go to the following link:

Presentation Information

For More Information:
Click on Workshops and Webinars in Spotlight box

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