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.

• FY 2010
• FY 2011
• FY 2012
• FY 2013
• All

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.

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).

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.