[Code of Federal Regulations]
[Title 21 Volume 5]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR316.12]

[Page 171]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 316--ORPHAN DRUGS--Table of Contents
 
  Subpart B--Written Recommendations for Investigations of Orphan Drugs
 
Sec. 316.12  Providing written recommendations.

    (a) FDA will provide the sponsor with written recommendations 
concerning the nonclinical laboratory studies and clinical 
investigations necessary for approval of a marketing application if none 
of the reasons described in Sec. 316.14 for refusing to do so applies.
    (b) When a sponsor seeks written recommendations at a stage of drug 
development at which advice on any clinical investigations, or on 
particular investigations would be premature, FDA's response may be 
limited to written recommendations concerning only nonclinical 
laboratory studies, or only certain of the clinical studies (e.g., Phase 
1 studies as described in Sec. 312.21 of this chapter). Prior to 
providing written recommendations for the clinical investigations 
required to achieve marketing approval, FDA may require that the results 
of the nonclinical laboratory studies or completed early clinical 
studies be submitted to FDA for agency review.