Zdrowie i gospodarka · 31/07/2019

FDA Requests Public Comment on Proposed Collection of Information for Biological Product Deviations and HCT/P Reporting

The Food and Drug Administration (FDA) is seeking public input on its proposed collection of information related to reporting of biological product deviations and human cells, tissues, and cellular and tissue-based product (HCT/P) deviations in manufacturing, as required by the Paperwork Reduction Act of 1995 (PRA). The public has 60 days to comment on the proposed collection, which was first solicited on July 31, 2019.