FDA SOPP 8116 Electronic Signatures

FDA Center for Biologics Evaluation and Research released SOPP 8116 “Using Electronic Signatures for Investigational and Marketing Regulatory Document Concurrence/Signoff” Version #4

Effective Date: August 10, 2010. This describes their approach to using electronic signatures for certain regulatory approvals (including correspondence and premarket submissions) and is based on applying each person’s network profile identification via the Adobe Electronic Signature Process. More information is at this link:  http://1.usa.gov/1bAnodB