Master Protocols for Drug and Biological Product Development; Draft Guidance for Industry; Extension of Comment Period
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Document details are published in the U.S. Federal Register; SPEQ surfaces them for reference and is not affiliated with or endorsed by the FDA or the Office of the Federal Register. The authoritative text is on federalregister.gov.
The Food and Drug Administration (FDA or the Agency) is extending the comment period for the notice of availability that published in the Federal Register of December 22, 2023. In that notice, FDA requested comments on the draft guidance for industry entitled, "Master Protocols for Drug and Biological Product Development." The Agency is taking this action in response to requests for an extension to allow interested persons additional time to submit comments.
Abstract as published in the Federal Register.
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