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U.S. Department of Health and Human Services

About FDA

Percentage of after hours Emergency Investigational New Drug (IND) requests that OCTEC addressed within two hours

Measure was implemented starting December 2010

Dictionary: Emergency INDs, described in 21 CFR 312.36, allow FDA to authorize use of an investigational drug in an emergency situation that does not allow time for submission of an IND in accordance with 21 CFR 312.23 or 312.34. All requests are urgent, so it is imperative that those received after normal business hours are addressed immediately. OCTEC serves as the CDER coordinator to provide immediate responses to after-hours emergency IND requests.

Fiscal Year - 2010

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Measure was implemented starting December 2010

TimeTargetPercent
Oct 2009N/AN/A
Nov 2009N/AN/A
Dec 2009N/AN/A
Jan 2010N/AN/A
Feb 2010N/AN/A
Mar 2010N/AN/A
Apr 2010N/AN/A
May 2010N/AN/A
Jun 2010N/AN/A
Jul 2010N/AN/A
Aug 2010N/AN/A
Sep 2010N/AN/A

Emergency IND requests addressed by OCTEC for CDER-regulated products after business hours including weekends and holidays

Dictionary: Emergency INDs, described in 21 CFR 312.36, allow FDA to authorize use of an investigational drug in an emergency situation that does not allow time for submission of an IND in accordance with 21 CFR 312.23 or 312.34. All requests are urgent, so it is imperative that those received after normal business hours are addressed immediately. OCTEC serves as the CDER coordinator to provide immediate responses to after-hours emergency IND requests.

Fiscal Year - 2010

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TimeTargetNumber
Oct 2009N/A22
Nov 2009N/A24
Dec 2009N/A7
Jan 2010N/A9
Feb 2010N/A9
Mar 2010N/A5
Apr 2010N/A5
May 2010N/A7
Jun 2010N/A4
Jul 2010N/A5
Aug 2010N/A5
Sep 2010N/A8

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.