• Decrease
  • Normal
  • Increase
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

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 - 2012

Skip graphic and jump to text data

TimeTargetPercent
Oct 2011N/A100
Nov 2011N/A100
Dec 2011N/A100
Jan 2012N/ATBD
Feb 2012N/ATBD
Mar 2012N/ATBD
Apr 2012N/ATBD
May 2012N/ATBD
Jun 2012N/ATBD
Jul 2012N/ATBD
Aug 2012N/ATBD
Sep 2012N/ATBD

FY 2012 Average: 100%

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 - 2012

Skip graphic and jump to text data

TimeTargetNumber
Oct 2011N/A7
Nov 2011N/A5
Dec 2011N/A4
Jan 2012N/ATBD
Feb 2012N/ATBD
Mar 2012N/ATBD
Apr 2012N/ATBD
May 2012N/ATBD
Jun 2012N/ATBD
Jul 2012N/ATBD
Aug 2012N/ATBD
Sep 2012N/ATBD

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.