CDER Issues Staff Manual on the Newly Identified Safety Signal Process
CDER laid out how it will review newly identified safety signals (NISS) for marketed drugs, in a new Manual of Policies and Procedures (MAPP).
Source: Drug GMP Report
CDER laid out how it will review newly identified safety signals (NISS) for marketed drugs, in a new Manual of Policies and Procedures (MAPP).
Source: Drug GMP Report