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
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Draft Guidance for Industry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

Zurück

GMP Seminare nach Thema