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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 June 30, 2014.

Fiscal Year - 2012

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TimeTargetNumber
Oct 2011N/A1
Nov 2011N/A2
Dec 2011N/A0
Jan 2012N/A-
Feb 2012N/A-
Mar 2012N/A-
Apr 2012N/A-
May 2012N/A-
Jun 2012N/A-
Jul 2012N/A0
Aug 2012N/A0
Sep 2012N/A4

FY 2012 6 month total: 7

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 - 2012

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TimeTargetNumber
Oct 2011N/A11
Nov 2011N/A10
Dec 2011N/A2
Jan 2012N/A-
Feb 2012N/A-
Mar 2012N/A-
Apr 2012N/A-
May 2012N/A-
Jun 2012N/A-
Jul 2012N/A7
Aug 2012N/A6
Sep 2012N/A1

FY 2012 6 month total: 37

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 - 2012

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TimeTargetNumber
Oct 2011N/A16
Nov 2011N/A21
Dec 2011N/A14
Jan 2012N/A-
Feb 2012N/A-
Mar 2012N/A-
Apr 2012N/A-
May 2012N/A-
Jun 2012N/A-
Jul 2012N/A11
Aug 2012N/A27
Sep 2012N/A13

FY 2012 6 Month Total: 102

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.