To
request a waiver to submit study data in a retired or unsupported format,
sponsors should submit a letter requesting a waiver to CDER-edata@fda.hhs.gov.
The following information should be contained in the request:
- 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
- A description of the submitter’s plan to become compliant with the guidance, including relevant timeframes.
To find more information please use the blow mentioned FDA
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