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-ReceiveStandards.
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- Clarify points in the draft guidance that have raised concerns/questions via Docket comments and feedback from a similar presentation delivered at the 2013 Generic Pharmaceutical Association Fall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- Answer further questions provoked by the draft guidance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: https://collaboration.fda.gov/sba1118/event/registration.html
(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 Jeffery.Rexrode@fda.hhs.gov 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:
https://collaboration.fda.gov/sba1118/event/login.html
Presentation Information
Guidance for Industry: ANDA Submissions – Refuse-to-ReceiveStandards
For More Information:
http://www.fda.gov/smallbusinessdrugs
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