FDA releases annual report on the status of postmarketing requirements (PMRs) and postmarketing commitments (PMCs) for FY2018 – Drug Information Update

FDA releases annual report on the status of postmarketing requirements (PMRs) and postmarketing commitments (PMCs) for FY2018

The U.S. Food and Drug Administration released the Annual Report on the Status of Postmarketing Requirements (PMRs) and Postmarketing Commitments (PMCs) for FY2018.  FDA is pleased to report that the majority of the PMRs/PMCs in the FY2018 report were successfully completed (fulfilled) or are progressing toward completion according to the original schedule; very few PMRs/PMCs are considered ‘delayed.’ The FDA is committed to ensuring that postmarketing requirements (PMRs) and postmarketing commitments (PMCs), which further describe the safety, efficacy, and/or optimal use of a drug, are conducted and reported as required. Please see the related Federal Register notice (document number 2019-16878) and the FDA’s PMR/PMC website for more information.