Advisory Committee Meetings

During the course of reviewing an application, CDER usually communicates often with sponsors about scientific, medical, and procedural issues that arise during the review process. Communications may take the form of telephone conversations, letters, faxes or meetings (either face-to-face or via videoconferencing).

CDER makes every effort to communicate promptly to applicants easily correctable deficiencies found during the review of an application. CDER also informs applicants of the need for more data or information, or for technical changes in the application needed to facilitate the agency's review. This type of early communication would not ordinarily apply to major scientific issues, which require consideration of the entire pending application by agency final decision makers as well as by reviewing staff. Instead, major scientific issues are usually addressed in an action letter at the end of the initial review process.

At the conclusion of CDER's review of an application, there are three possible action letters that can be sent to the sponsor:

Not Approvable Letter	Lists the deficiencies in the application and explains why the application cannot be approved.
Approvable Letter	Signals that, ultimately, the drug can be approved. Lists minor deficiencies that can be corrected, often involves labeling changes, and possibly requests commitment to do post-approval studies.
Approval Letter	States that the drug is approved. May follow an approvable letter, but can also be issued directly.

If the action taken is either an approvable or a not approvable action (as opposed to an approval action), CDER provides applicants with an opportunity to meet with Agency officials and discuss the deficiencies. The purpose of this "end of review conference" is to discuss what further steps are necessary before the application can be approved. This meeting is available on all applications, with priority given to applications for priority review drugs and major new indications for marketed drugs. Requests for such meetings are directed to the director of the division responsible for reviewing the application.

Other meetings between CDER and applicants may be held to discuss scientific, medical, and other issues that arise during the review process. CDER makes every effort to grant requests for meetings that involve important issues and that can be scheduled at mutually convenient times.

For more information on meetings between CDER and applicants, see MAPP 4512.1, "Formal Meetings Between CDER and CDER's External Constituents".