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 draftGuidance 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 The draft guidance provides a qualitative systematic framework for evaluating proprietary names before submitting them for FDA review.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: https://collaboration.fda.gov/sbia070714/event/registration.html

(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

- Draft Guidance for Industry: Best Practices in Developing Proprietary Names for Drugs

For questions concerning the webinar, please contact CDER SBIA at:

(866)-405-5367 | (301)-796-6707

CDER SBIA webinar series: http://www.fda.gov/Drugs/DevelopmentApprovalProcess/SmallBusinessAssistance/ucm070334.htm