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A follow-up webinar will be offered to individuals responsible for the preparation and submission of drug registration and listing information to the FDA. (Please feel free to forward this invitation to those who might be interested.) This webinar will cover real-world examples of Establishment Registration and Drug Listings. Attendees at the February Webinar and/or Face-to-Face meetings will benefit from this follow-up, as would anyone who is familiar with the Draft Structured Product Labeling Implementation Guide for FDA Drug Registration and Listing.
Examples Needed: This webinar will rely on examples from Establishment Registration and Drug Listings provided by pharmaceutical, biologic, OTC and animal products sponsors, labelers, manufacturers, distributors, etc. Please send examples (from the straightforward to the complex) to spl@fda.hhs.gov. Include in the e-mail title "EXAMPLE FOR WEBINAR". Remember, the success of this webinar depends on receiving real-world examples.
Background: The FDA Amendments Act placed into law the requirement for electronic establishment registration and drug listing. Release 4 of Structured Product Labeling (SPL) contains data elements that could enable this process.
Targeted audience: Attendees of February Webinar or Face-to-Face are strongly encouraged to attend. Additionally, individuals responsible for establishment registration and drug listing for pharmaceutical, biologic, OTC and animal products who have reviewed the SPL Release 4 validation rules and implementation guides are strongly encouraged to attend.
1. SPL Release Four Evaluation Material for Registration and Listing
2. FDA Amendment Act of 2007 - Section 224 - Electronic Registration and Listing
Date: Wednesday, April 2, 2008
Time: 1:00 p.m. – 2:30 p.m. EST
There is no registration fee for this training session, but pre-registration is required because of limited connections for the webinar. To register, please submit your first and last name and the name of your organization to spl@fda.hhs.gov.
For further information, contact: spl@fda.hhs.gov.