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.