Content and Review of Chemistry, Manufacturing, and Control (CMC) Information for Human Somatic Cell Therapy Investigational New Drug Applications (INDs): Guidance for FDA Reviewers and Sponsors
Detailed guidance document from FDA and regulatory agencies.
Document Details
Guidance Document
April 1, 2008
February 3, 2025
b31bbe0c-42aa-4671-a86f-7bc15821926b
Related Documents
Collection of Platelets by Automated Methods: Guidance for Industry and FDA Review Staff
Guidance DocumentDecember 1, 2007Center for Biologics Evaluation and Research
Manufacturing Biological Intermediates and Biological Drug Substances Using Spore-Forming Microorganisms: Guidance for Industry
Guidance DocumentSeptember 1, 2007Center for Biologics Evaluation and Research
Eligibility Determination for Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products: Guidance for Industry
Guidance DocumentAugust 8, 2007Center for Biologics Evaluation and Research
Quick Actions
Transform Regulatory Data into Actionable Intelligence
Join leading pharmaceutical and medical device companies who trust KeyPedia for their regulatory compliance needs.