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U.S. Department of Health and Human Services

About FDA

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 - 2011

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Oct 2010N/A2
Nov 2010N/A1
Dec 2010N/A2
Jan 2011N/A1
Feb 2011N/A1
Mar 2011N/A3
Apr 2011N/A4
May 2011N/A0
Jun 2011N/A2
Jul 2011N/A2
Aug 2011N/A1
Sep 2011N/A2

FY 2011 Total: 21


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.