Number of ONDQA correspondences with applicants associated with the Chemistry, Manufacturing, and Controls (CMC) review of Investigational New Drugs (INDs), New Drug Applications (NDAs), or supplements to New Drug Applications (sNDAs) occurred within the month (1)
Dictionary: In the course of the review of IND, NDA, or supplemental NDA submissions, interactions with the sponsor or applicant is beneficial to request additional information, clarify information submitted in the application, and communicate decisions made regarding the application. These correspondences include all communications by ONDQA staff, either written or orally communicated, associated with the review of chemistry, manufacturing, and controls information submitted in IND, NDA, supplemental NDA, or DMF submissions.
This measure has been retired as CDER has created new measures for FY13 which 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.
Fiscal Year - 2012
FY 2012 YTD: 845
- (1) These official documents and correspondences include, but are not limited to, information requests and advice communications (either written or orally communicated), as well as action letters.
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.