The Food and Drug Administration (FDA) has submitted a proposal to the Office of Management and Budget (OMB) for review, seeking to extend the collection of information related to drug, biological product, and device applications under the Paperwork Reduction Act. This involves certifications that accompany these submissions to ensure compliance with legal standards, including listing data for clinical trials in a registry. The FDA estimates that it will take approximately 15 to 45 minutes to complete the necessary certification forms, depending on the type of application, and aims to simplify compliance for sponsors and applicants. No public comments were received on this proposal when it was initially published.
Simple Explanation
The FDA wants to make sure that when people apply to use new medicines or medical tools, they fill out a form to show they’re following all the rules. They say filling out this form should only take a little bit of time.