What is the difference between Mandatory and Voluntary reporting?
Under certain circumstances, some organizations are required by statute or regulation to submit a safety report to the Federal Government. When a report is required by statute or regulation, the report is termed a “Mandatory” report. Reports that are not required by statute or regulation are termed “Voluntary” reports. The following Mandatory reports can be submitted on the Safety Reporting Portal at this time: • Reportable Food Report, a safety report on a Reportable Food sent by a registered Food Facility or responsible party that manufactures, processes, packs or holds food for human or animal consumption in the U.S. • Animal Drug Safety Report, a report on an adverse event and/or product problem with an animal drug; sent by a Marketing Authorization Holder, or their representative • Gene Transfer Research Adverse Event Report, for adverse events that occur during NIH sponsored gene transfer clinical trials; sent by a principal investigator or a member of the research team Other Man
