Guidance for Industry: Chemistry, Manufacturing, and Controls Changes to an Approved Application: Certain Biological Products
Title:
Guidance for Industry: Chemistry, Manufacturing, and
Controls Changes to an Approved
Application: Certain Biological
Products
Origin/Publisher:
U.S. Department of Health and Human Services Food and Drug Administration Center for Biologics Evaluation and Research Center for Drugs Evaluation and Research
Document Type:
Draft Guidance for Industry
Content:
Assistance with the classification and evaluation of manufacturing changes in licensed biological products