Postmarketing Requirements and Commitments: Searchable Database
This searchable database includes PMRs and 506B PMCs which are those studies and trials for clinical safety, clinical efficacy, clinical pharmacology, and nonclinical toxicology. It also includes all open PMRs and 506B PMCs and only those closed (released or fulfilled) within the last year.
Update frequency: Quarterly; generally, on or around the end of January, April, July, and October
Additional PMR/PMC Resources:
Introduction | Reports | Legislative Background | FAQ | Status and Fulfillment Categories | Downloadable Database File
FDA Home | Drugs Home | Vaccines, Blood & Biologics Home
For questions about PMRs/PMCs: pmcweb@fda.hhs.gov