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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
Measure was implemented starting December 2010
| Time | Target | Percent |
|---|---|---|
| Oct 2009 | N/A | N/A |
| Nov 2009 | N/A | N/A |
| Dec 2009 | N/A | N/A |
| Jan 2010 | N/A | N/A |
| Feb 2010 | N/A | N/A |
| Mar 2010 | N/A | N/A |
| Apr 2010 | N/A | N/A |
| May 2010 | N/A | N/A |
| Jun 2010 | N/A | N/A |
| Jul 2010 | N/A | N/A |
| Aug 2010 | N/A | N/A |
| Sep 2010 | N/A | N/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
| Time | Target | Number |
|---|---|---|
| Oct 2009 | N/A | 22 |
| Nov 2009 | N/A | 24 |
| Dec 2009 | N/A | 7 |
| Jan 2010 | N/A | 9 |
| Feb 2010 | N/A | 9 |
| Mar 2010 | N/A | 5 |
| Apr 2010 | N/A | 5 |
| May 2010 | N/A | 7 |
| Jun 2010 | N/A | 4 |
| Jul 2010 | N/A | 5 |
| Aug 2010 | N/A | 5 |
| Sep 2010 | N/A | 8 |
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.
