Guidance for Industry: Chemistry, Manufacturing, and Controls Changes to an Approved Application: Certain Biological Products
Titel:
Guidance for Industry: Chemistry, Manufacturing, and
Controls Changes to an Approved
Application: Certain Biological
Products
Internet:
Herkunft/Verlag:
U.S. Department of Health and Human Services Food and Drug Administration Center for Biologics Evaluation and Research Center for Drugs Evaluation and Research
Dokumentenart:
Draft Guidance for Industry
Inhalt:
Hilfestellung bei der Einstufung und Bewertung von Herstelländerungen bei lizensierten biologischen Produkten