Proposed Approach to Regulation of Cellular and Tissue-Based Products
Detailed guidance document from FDA and regulatory agencies.
Document Details
Guidance Document
February 28, 1997
July 26, 2024
d4c69ac2-d93b-4834-9b6f-c6a4c0387ab9
Related Documents
Premarket Notification Submissions for Transfer Sets (Excluding Sterile Connecting Devices): Guidance for FDA Reviewers
Guidance DocumentJuly 19, 2001Center for Biologics Evaluation and Research
Guidance for Industry for the Evaluation of Combination Vaccines for Preventable Diseases: Production, Testing and Clinical Studies: Guidance for Industry
Guidance DocumentApril 10, 1997Center for Biologics Evaluation and Research
Premarket Notification Submissions for Blood and Plasma Warmers: Guidance for FDA Reviewers
Guidance DocumentJuly 19, 2001Center for Biologics Evaluation and Research
Quick Actions
Transform Regulatory Data into Actionable Intelligence
Join leading pharmaceutical and medical device companies who trust GKS for their regulatory compliance needs.
Try KeyPedia Today
Explore our real use cases and discover our features in depth.
Stay ahead of FDA enforcement
New KeyPedia insights, webinars, and regulatory analysis — straight to your inbox. Unsubscribe anytime.