Number of Scientific and Review Publications published within the month
Dictionary: The Office of Biotechnology Products (OBP) has laboratories that perform research in areas that inform review and policy for OBP products. These areas include manufacturing science (e.g. Quality by Design, Process Analytical technology, Viral Safety), structural characterization, biological characterization (Potency Bioassays, Mechanisms of Action, Biological Models) and linking quality to safety and efficacy (Immunogenicity, Epidemiology). Our presentations and publications reflect work in these areas.
This measure has been retired as CDER has created new measures for FY13 which align to their four functional areas of 1) Regulatory Review and Drug Safety, 2) Drug Quality and Compliance, 3) Transparency and Public Outreach, and 4) Regulatory Science Research.
Fiscal Year - 2012
FY 2012 YTD: 12
Note: The data provided on this website is produced on an ongoing basis for performance management purposes and is subject to change due to updates of preliminary estimates, corrections, or other reasons. In addition, FDA may change the type or amount of data provided on this website at any time. Information marked as "Completed" may include measures and/or key projects for which activities are ongoing but no longer tracked as part of FDA-TRACK.