Zdrowie i gospodarka · 21/10/2020

FDA Announces Draft Guidance for Industry on Annual Status Report Information and Other Submissions for Postmarketing Requirements and Commitments

The Food and Drug Administration (FDA) has released a draft guidance document outlining the use of specific forms (FDA 3988 and FDA 3989) for submitting postmarketing requirements and commitments for drugs and biologics, aiming to standardize the process and reduce manual data entry.