Drugs

Guidelines for requesting waiver to current supported clinical study data standard versions

At this time, submitting study data in standardized format is voluntary, so a waiver is not needed to submit study data in non-standardized format.  If standardized study data is submitted, it should use one of the currently supported versions identified in the Catalog below.

 

The currently supported versions of clinical 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 FDA technical staff at cder-edata@fda.hhs.gov for requests related to IND, NDA, or ANDA submissions or cber.cdisc@fda.hhs.gov for requests related to BLA submissions. The subject line of the email should start with “Waiver Request.” The body of the email should contain the following:

1. Contact person’s name (this will be the main contact)
2. Contact person’s company name
3. Contact person’s mailing address
4. Contact person’s phone number
5. Contact person’s email address
6. Relevant submission types and numbers
7. The specific requirement or requirements from which the sponsor or applicant is requesting a waiver
8. The reason the sponsor or applicant believes that the waiver is necessary
9. A description of the alternative or alternatives that the sponsor intends to use.
 
FDA encourages the sponsor or applicant to submit the waiver request to the FDA technical staff as early as possible during product development (e.g., when the study is being planned, which may be during the pre-IND phase) and certainly no later than the time of protocol submission to the IND. FDA will notify the sponsor or applicant in writing (e.g., in an email) as to whether the waiver request is denied or granted. The technical staff will coordinate with the applicable review division and contact the requestor concerning the status of the waiver request. Generally, FDA intends to notify the requestor within 30 days from the date the waiver request is received.

 

Page Last Updated: 12/18/2014
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