Guidelines for Requesting Waiver to Current Supported Study Data Standard Versions
The currently supported versions of study data standards are identified in the FDA Study Data Standards Catalog.
To apply for a waiver from the requirement to submit study data using a version of a standard that is not supported as set forth in the Catalog, an email request must be sent to the appropriate FDA technical staff. For CDER-regulated IND, NDA, BLA, or ANDA submissions, requests should be addressed to: email@example.com. For CBER-regulated IND, BLA, or NDA submissions, requests should be addressed to: firstname.lastname@example.org. The subject line of the email should start with “Waiver Request.” The body of the email should contain the following:
- Contact person’s name (this will be the main contact)
- Contact person’s company name
- Contact person’s mailing address
- Contact person’s phone number
- Contact person’s email address
- Relevant submission types and numbers
- The specific requirement or requirements from which the sponsor or applicant is requesting a waiver
- The reason the sponsor or applicant believes that the waiver is necessary
- A description of the alternative or alternatives that the sponsor intends to use.