GUIDANCE DOCUMENT
eCTD TECHNICAL CONFORMANCE GUIDE December 2019
- Docket Number:
- FDA-2017-D-6821
- Issued by:
-
Guidance Issuing OfficeCenter for Biologics Evaluation and ResearchCenter for Drug Evaluation and Research
This technical specifications document represents the current thinking of the Food and Drug Administration (FDA or Agency) on this topic. It does not create any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations. To discuss an alternative approach, contact the FDA staff responsible for implementing this specifications document by email at esub@fda.hhs.gov or esubprep@fda.hhs.gov.
Submit Comments
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If unable to submit comments online, please mail written comments to:
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All written comments should be identified with this document's docket number: FDA-2017-D-6821.