Zdrowie i gospodarka · 27.10.1994
Guideline for Adverse Experience Reporting for Licensed Biological Products; Availability
The Food and Drug Administration (FDA) is announcing the availability of a guideline entitled ``Guideline for Adverse Experience Reporting for Licensed Biological Products.'' The purpose of this guideline is to assist manufacturers of biological products in developing and implementing procedures to report to FDA adverse experiences associated with biological products. Elsewhere in this issue of the Federal Register, FDA is issuing a final rule amending the biologics regulations to which this guideline applies.