Revised Recommendations Regarding Invalidation of Test Results of Licensed and 510(k) Cleared Bloodborne Pathogen Assays Used to Test Donors: Guidance for Industry
Detailed guidance document from FDA and regulatory agencies.
Document Details
Guidance Document
July 11, 2001
June 21, 2024
0cda0e13-b5d9-4c9c-874d-d7dd38e5de33
Related Documents
Efficacy Studies to Support Marketing of Fibrin Sealant Products Manufactured for Commercial Use: Guidance for Industry
Guidance DocumentMay 20, 1999Center for Biologics Evaluation and Research
Recommendations for Collecting Red Blood Cells by Automated Apheresis Methods - Technical Correction February 2001: Guidance for Industry
Guidance DocumentFebruary 13, 2001Center for Biologics Evaluation and Research
Guidance for Industry: Providing Regulatory Submissions to CBER in Electronic Format -- Investigational New Drug Applications (INDs) (PDF)
Guidance DocumentMarch 1, 2002Center 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.
Subscribe to our newsletter
Get the latest updates and insights delivered to your inbox