[Code of Federal Regulations]
[Title 21, Volume 5]
[Revised as of April 1, 2008]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR314.102]

[Page 136-137]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF 
 
PART 314_APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW DRUG--
Table of Contents
 
    Subpart D_FDA Action on Applications and Abbreviated Applications
 
Sec. 314.102  Communications between FDA and applicants.

    (a) General principles. During the course of reviewing an 
application or an abbreviated application, FDA shall communicate with 
applicants about scientific, medical, and procedural issues that arise 
during the review process. Such communication may take the form of 
telephone conversations, letters, or meetings, whichever is most 
appropriate to discuss the particular issue at hand. Communications 
shall be appropriately documented in the application in accordance with 
Sec. 10.65 of this chapter. Further details on the procedures for 
communication between FDA and applicants are contained in a staff manual 
guide that is publicly available.
    (b) Notification of easily correctable deficiencies. FDA reviewers 
shall make every reasonable effort to communicate promptly to applicants 
easily

[[Page 137]]

correctable deficiencies found in an application or an abbreviated 
application when those deficiencies are discovered, particularly 
deficiencies concerning chemistry, manufacturing, and controls issues. 
The agency will also inform applicants promptly of its need for more 
data or information or for technical changes in the application or the 
abbreviated application needed to facilitate the agency's review. This 
early communication is intended to permit applicants to correct such 
readily identified deficiencies relatively early in the review process 
and to submit an amendment before the review period has elapsed. Such 
early communication would not ordinarily apply to major scientific 
issues, which require consideration of the entire pending application or 
abbreviated application by agency managers as well as reviewing staff. 
Instead, major scientific issues will ordinarily be addressed in an 
action letter.
    (c) Ninety-day conference. Approximately 90 days after the agency 
receives the application, FDA will provide applicants with an 
opportunity to meet with agency reviewing officials. The purpose of the 
meeting will be to inform applicants of the general progress and status 
of their applications, and to advise applicants of deficiencies that 
have been identified by that time and that have not already been 
communicated. This meeting will be available on applications for all new 
chemical entities and major new indications of marketed drugs. Such 
meetings will be held at the applicant's option, and may be held by 
telephone if mutually agreed upon. Such meetings would not ordinarily be 
held on abbreviated applications because they are not submitted for new 
chemical entities or new indications.
    (d) End of review conference. At the conclusion of FDA's review of 
an application or an abbreviated application as designated by the 
issuance of an approvable or not approvable letter, FDA will provide 
applicants with an opportunity to meet with agency reviewing officials. 
The purpose of the meeting will be to discuss what further steps need to 
be taken by the applicant before the application or abbreviated 
application can be approved. This meeting will be available on all 
applications or abbreviated applications, with priority given to 
applications for new chemical entities and major new indications for 
marketed drugs and for the first duplicates for such drugs. Requests for 
such meetings shall be directed to the director of the division 
responsible for reviewing the application or abbreviated application.
    (e) Other meetings. Other meetings between FDA and applicants may be 
held, with advance notice, to discuss scientific, medical, and other 
issues that arise during the review process. Requests for meetings shall 
be directed to the director of the division responsible for reviewing 
the application or abbreviated application. FDA will make every attempt 
to grant requests for meetings that involve important issues and that 
can be scheduled at mutually convenient times. However, ``drop-in'' 
visits (i.e., an unannounced and unscheduled visit by a company 
representative) are discouraged except for urgent matters, such as to 
discuss an important new safety issue.

[57 FR 17988, Apr. 28, 1992; 57 FR 29353, July 1, 1992]