When does the rescission of Direct Reference Authority begin?
FDA District Offices are being advised that Direct Reference Authority for issuing Warning Letters will be rescinded on February 28, 2003. Beginning in March 2003, the Centers will begin reviewing warning letters proposed by the District Offices. 7. Why are all drug cGMP Warning Letters now going to be reviewed by the Centers? This will help identify possible program inconsistencies and resolve them before warning letters are issued. 8. Will the Centers/FDA be doing any kind of evaluation of the inspectional information supporting proposed Warning Letters? Yes, regular analysis of these data will aid the Centers in identifying trends used to further develop a risk-based strategy towards cGMP enforcement practices. FDA can also use this knowledge to enhance policy, provide guidance, and establish training for the FDA field staff and regulated industry. 9. What are some of the inconsistencies that FDA is trying to eliminate and why? As innovative manufacturing and control technologies ar
