Meetings with Sponsor
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).
Notification of Easily Correctable Deficiencies
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.
End of Review Conference
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
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".
Source: U.S. Food and Drug Administration Center for Drug Evaluation and Research Handbook.
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