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U.S. Department of Health and Human Services

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Number of presentations to external stakeholders

Dictionary: OCTEC provides presentations at public meetings to facilitate drug development on medical countermeasures (MCM) against the effects of chemical, biological, radiological, and nuclear (CBRN) agents. Sponsors of such MCM are often small companies or other federal agencies with limited drug development experience and the need for assistance in navigating the complexities of FDA.

Information is current as of September 30, 2014.

Fiscal Year - 2010

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TimeTargetNumber
Oct 2009N/A1
Nov 2009N/A2
Dec 2009N/A1
Jan 2010N/A1
Feb 2010N/A0
Mar 2010N/A2
Apr 2010N/A1
May 2010N/A1
Jun 2010N/A3
Jul 2010N/A0
Aug 2010N/A1
Sep 2010N/A1

Footnotes

  • From January 2012 to July 2012, CDER was in the process of reorganizing their FDA-TRACK Dashboard to better 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. Therefore, FY12 will have missing data during that period.

Number of interactions with sponsors on drug development (meetings, telecons, significant correspondence)

Dictionary: OCTEC provides early consultation to sponsors of MCM to assist them as they begin their development process, via teleconferences, meetings, and significant correspondence. OCTEC continues to be involved throughout the drug development process by participating in review divisions' sponsor meetings to provide scientific consultation for special issues related to MCM against CBRN agents, including MCM for the military, products held by the Strategic National Stockpile, and Emergency Use Authorization.

Fiscal Year - 2010

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TimeTargetNumber
Oct 2009N/A15
Nov 2009N/A14
Dec 2009N/A8
Jan 2010N/A6
Feb 2010N/A1
Mar 2010N/A11
Apr 2010N/A13
May 2010N/A10
Jun 2010N/A9
Jul 2010N/A6
Aug 2010N/A2
Sep 2010N/A5

Footnotes

  • From January 2012 to July 2012, CDER was in the process of reorganizing their FDA-TRACK Dashboard to better 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. Therefore, FY12 will have missing data during that period.

Number of interagency working group meetings for facilitation of drug development

Dictionary: OCTEC represents the Center or agency as a liaison to provide input on areas of unmet medical needs related to counter-terrorism drug modalities (e.g., whether drugs are approved and/or labeled for the specific intended use).

Fiscal Year - 2010

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TimeTargetNumber
Oct 2009N/A10
Nov 2009N/A8
Dec 2009N/A5
Jan 2010N/A3
Feb 2010N/A2
Mar 2010N/A19
Apr 2010N/A14
May 2010N/A8
Jun 2010N/A8
Jul 2010N/A7
Aug 2010N/A15
Sep 2010N/A4

Footnotes

  • From January 2012 to July 2012, CDER was in the process of reorganizing their FDA-TRACK Dashboard to better 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. Therefore, FY12 will have missing data during that period.

Glossary

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.