U.S. Food & Drug Administration (FDA) CBER's Guidances Update

Guidance for Industry and Investigators Safety Reporting Requirements for INDs and BA/BE Studies (PDF - 216KB)
Posted: 12/21/2012
Guidance for Industry and Investigators Safety Reporting Requirements for INDs and BA/BE Studies - Small Entity Compliance Guide (PDF - 29KB)
Posted: 12/21/2012