Federal award (DEFINITIVE CONTRACT, fiscal year 2021)
Recipient: BRIGHAM & WOMENS HOSPITAL INC
Awarding agency: Department of Health and Human Services / Food and Drug Administration
Funding agency: Department of Health and Human Services / Food and Drug Administration
Period of performance: 2022-09-27 to 2025-09-27
Current total value of award: $2708850
Description: DESIGN A TWO-STAGE PROCESS FOR USING RWE TO SUPPORT LABELING EXPANSIONS FOR EFFECTIVENESS CLAIMS THAT IS ALIGNED WITH REGULATORY REQUIREMENTS/DEMONSTRATE AND EMPIRICALLY TEST THE PROCESS WITH HISTORICAL AND ONGOING RCTS FOR SUPPLEMENTAL INDICATIONS/