martes, 1 de julio de 2014

CDER SBIA Webinar: An Overview of FDA’s Proprietary Name Review Process - July 7, 2014

FDA/CDER's Small Business and Industry Assistance (CDER SBIA)

CDER SBIA Webinar on “Overview of FDA’s Proprietary Name Review Process”

On Monday July 7, 2014 at 1:30 pm EDT, CDER SBIA will host a webinar entitled Overview of FDA’s Proprietary Name Review Process.”

FDA published a notice in the Federal Register announcing the availability of the draft Guidance for Industry - Best Practices in Developing Proprietary Names for Drugs.

This webinar will provide an overview of the Proprietary Name Review guidance that focuses on the safety aspects in the development and selection of proposed proprietary names for all prescription and nonprescription drug products and biological products. The draft guidance provides a qualitative systematic framework for evaluating proprietary names before submitting them for FDA review. FDA is issuing this guidance to help sponsors of drug and biological products develop proprietary names that are not potentially misleading and do not cause or contribute to medication errors. This webinar will go over the guidance that represents FDA’s current thinking on this topic.

To register for this Event, please go the following link:
(Registration password needs to be 8 characters and alphanumeric)

Note: Your registration acknowledgement will include the webinar access link. 
Audio will broadcast from your computer speakers.
Closed captioning will be provided.

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.

Questions/Comments can be submitted live via a Q/A chat window.
- FR Document: 2014–12348
- Docket ID: FDA-2014-D-0622

For questions concerning the webinar, please contact CDER SBIA at:
(866)-405-5367 | (301)-796-6707


The Small Business and Industry Assistance program in the Center for Drug Evaluation and Research (CDER SBIA) provides guidance and information to regulated domestic and international small pharmaceutical business and industry through its website, email notifications, and workshops. This notification system provides current information from CDER/FDA via e-mail on a biweekly basis that is relevant to small pharmaceutical business, which includes Federal Register notices, guidances, workshop announcements, etc. This is an automated message delivery system. Replying to this message will not reach the CDER SBIA staff. If you have comments or questions, please contact us Monday through Friday 8:00AM - 4:30PM.
Please take our CDER Small Business survey:

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