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U.S. Department of Health and Human Services

About FDA

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.

Fiscal Year - 2013

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TimeTargetNumber
Oct 2012N/A2
Nov 2012N/A1
Dec 2012N/A0
Jan 2013N/ATBD
Feb 2013N/ATBD
Mar 2013N/ATBD
Apr 2013N/ATBD
May 2013N/ATBD
Jun 2013N/ATBD
Jul 2013N/ATBD
Aug 2013N/ATBD
Sep 2013N/ATBD

FY 2013 YTD: 3

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 - 2013

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TimeTargetNumber
Oct 2012N/A1
Nov 2012N/A10
Dec 2012N/A2
Jan 2013N/ATBD
Feb 2013N/ATBD
Mar 2013N/ATBD
Apr 2013N/ATBD
May 2013N/ATBD
Jun 2013N/ATBD
Jul 2013N/ATBD
Aug 2013N/ATBD
Sep 2013N/ATBD

FY 2013 YTD: 13

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 - 2013

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TimeTargetNumber
Oct 2012N/A5
Nov 2012N/A9
Dec 2012N/A8
Jan 2013N/ATBD
Feb 2013N/ATBD
Mar 2013N/ATBD
Apr 2013N/ATBD
May 2013N/ATBD
Jun 2013N/ATBD
Jul 2013N/ATBD
Aug 2013N/ATBD
Sep 2013N/ATBD

FY 2013 YTD: 22

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.