Technology 04 n 0133-emc-000022-01 (1)

1. 21 CFR PART 11 REGULATIONS21 CFR PART 11 REGULATIONSRECOMMENDATIONS FOR CHANGESRECOMMENDATIONS FOR CHANGESFDA PUBLIC MEETING ON PART 11FDA PUBLIC MEETING ON PART 11REGULATIONS…

Documents 1/22 Potential Next Steps Jay E. Slater, MD Director, DBPAP.

Potential Next Steps Jay E. Slater, MD Director, DBPAP Todayâs presentations Background Allergenics efficacy reviews Panel 1, 21 CFR 601.25 (1974-1979) Panel 2, 21 CFR 601.26…