Manufacturing Changes and Comparability for Human Cellular and Gene Therapy Products; Draft Guidance for Industry; Extension of the Comment Period
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Issuing agencies
Abstract
The Food and Drug Administration (FDA or we) is extending the comment period for the notice announcing the availability of a draft guidance entitled "Manufacturing Changes and Comparability for Human Cellular and Gene Therapy Products; Draft Guidance for Industry," that appeared in the Federal Register of July 14, 2023. We are taking this action in response to requests for an extension to allow interested persons additional time to submit comments.
This is legal information, not legal advice. Laws vary by jurisdiction and change frequently. Always verify current law with official sources and consult a licensed attorney in your jurisdiction for advice on your specific situation.