[Code of Federal Regulations]
[Title 21, Volume 5]
[Revised as of April 1, 2007]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR312.48]

[Page 74]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 312_INVESTIGATIONAL NEW DRUG APPLICATION--Table of Contents
 
                    Subpart C_Administrative Actions
 
Sec.  312.48  Dispute resolution.

    (a) General. The Food and Drug Administration is committed to 
resolving differences between sponsors and FDA reviewing divisions with 
respect to requirements for IND's as quickly and amicably as possible 
through the cooperative exchange of information and views.
    (b) Administrative and procedural issues. When administrative or 
procedural disputes arise, the sponsor should first attempt to resolve 
the matter with the division in FDA's Center for Drug Evaluation and 
Research or Center for Biologics Evaluation and Research which is 
responsible for review of the IND, beginning with the consumer safety 
officer assigned to the application. If the dispute is not resolved, the 
sponsor may raise the matter with the person designated as ombudsman, 
whose function shall be to investigate what has happened and to 
facilitate a timely and equitable resolution. Appropriate issues to 
raise with the ombudsman include resolving difficulties in scheduling 
meetings and obtaining timely replies to inquiries. Further details on 
this procedure are contained in FDA Staff Manual Guide 4820.7 that is 
publicly available under FDA's public information regulations in part 
20.
    (c) Scientific and medical disputes. (1) When scientific or medical 
disputes arise during the drug investigation process, sponsors should 
discuss the matter directly with the responsible reviewing officials. If 
necessary, sponsors may request a meeting with the appropriate reviewing 
officials and management representatives in order to seek a resolution. 
Requests for such meetings shall be directed to the director of the 
division in FDA's Center for Drug Evaluation and Research or Center for 
Biologics Evaluation and Research which is responsible for review of the 
IND. FDA will make every attempt to grant requests for meetings that 
involve important issues and that can be scheduled at mutually 
convenient times.
    (2) The ``end-of-Phase 2'' and ``pre-NDA'' meetings described in 
Sec.  312.47(b) will also provide a timely forum for discussing and 
resolving scientific and medical issues on which the sponsor disagrees 
with the agency.
    (3) In requesting a meeting designed to resolve a scientific or 
medical dispute, applicants may suggest that FDA seek the advice of 
outside experts, in which case FDA may, in its discretion, invite to the 
meeting one or more of its advisory committee members or other 
consultants, as designated by the agency. Applicants may rely on, and 
may bring to any meeting, their own consultants. For major scientific 
and medical policy issues not resolved by informal meetings, FDA may 
refer the matter to one of its standing advisory committees for its 
consideration and recommendations.

[52 FR 8831, Mar. 19, 1987, as amended at 55 FR 11580, Mar. 29, 1990]