Electronic Submission of FDA Adverse Event Reports and Other Safety Information Using the Electronic Submission Gateway and the Safety Reporting Portal
0645 IC2 CVM adverse drug experiences and product defects RQ screenshots 2013
Mandatory Adverse Event Reporting via the SRP
OMB: 0910-0645
⚠️ Notice: This form may be outdated. More recent filings and information on OMB 0910-0645 can be found here: