The Food and Drug Administration (FDA) is inviting public comments on its proposed information collection related to adverse experience reporting for licensed biological products. This reporting is crucial for identifying serious safety issues with these products after they have been marketed. The FDA requires that manufacturers report adverse experiences quickly and periodically, and also maintain detailed records for a certain number of years. Public comments can be submitted through the designated OMB website by March 25, 2021.
Simple Explanation
The FDA wants to hear from people about how they collect important safety information on certain medicines, which helps keep people safe after the medicines are sold. They are asking for comments and want to know what people think before March 25, 2021.