Zdrowie i gospodarka · 03/08/1994
FDA Announces Availability of Draft Points to Consider Document for Monoclonal Antibody Products
The FDA is announcing the availability of a draft points to consider document to assist sponsors and investigators of monoclonal antibody products intended for human use, revising a 1987 document with updated guidance from the Center for Biologics Evaluation and Research.
Source: Federal Register — Health and Human ServicesOpen original release →