New drugs regulatory modernization transition project support
Type: Forecast
Overview
Description
DER/OND Safety Staff directly support the following strategic objectives: scientific leadership, integrated assessment, knowledge management, and benefit-risk monitoring. The Postmarket Safety workstream of the New Drugs Regulatory Program developed the Pharmacovigilance (PV) Framework to support efficient and effective safety review in the 21st Century. The Framework includes several initiatives, such as Drugs Safety Teams, Pharmacovigilance Strategy, Integrated Safety Assessment, and Essentials of Drug Safety Curriculum, and refined operating model, that have been initiated but are in need of evaluation and refinement.
Est. Value
Min: $1,500,000
Max: $3,000,000
Max: $3,000,000
Est. Award Date
7/1/24
Source Est. Solicitation Date
1/1/24
Set Aside
Full and Open
Forecast Source
Food and Drug Administration is forecasted to issue a procurement for New drugs regulatory modernization transition project support around 7/1/24 worth up to $3,000,000.
Agency
Source Level 1 Agency
Health and Human Services
Source Level 2 Agency
Food and Drug Administration
Contacts
Potential Bidders and Partners
Similar Active Opportunities
Additional Detail
Date Published
9/1/23