[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: 21CFR310.303]

[Page 18]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 310_NEW DRUGS--Table of Contents
 
                      Subpart D_Records and Reports
 
Sec.  310.303  Continuation of long-term studies, records, and reports on 


certain drugs for which new drug applications have been approved.

    (a) A new drug may not be approved for marketing unless it has been 
shown to be safe and effective for its intended use(s). After approval, 
the applicant is required to establish and maintain records and make 
reports related to clinical experience or other data or information 
necessary to make or facilitate a determination of whether there are or 
may be grounds under section 505(e) of the act for suspending or 
withdrawing approval of the application. Some drugs, because of the 
nature of the condition for which they are intended, must be used for 
long periods of time--even a lifetime. To acquire necessary data for 
determining the safety and effectiveness of long-term use of such drugs, 
extensive animal and clinical tests are required as a condition of 
approval. Nonetheless, the therapeutic or prophylactic usefulness of 
such drugs may make it inadvisable in the public interest to delay the 
availability of the drugs for widespread clinical use pending completion 
of such long-term studies. In such cases, the Food and Drug 
Administration may approve the new drug application on condition that 
the necessary long-term studies will be conducted and the results 
recorded and reported in an organized fashion. The procedures required 
by paragraph (b) of this section will be followed in order to list such 
a drug in Sec.  310.304.
    (b) A proposal to require additional or continued studies with a 
drug for which a new drug application has been approved may be made by 
the Commissioner on his own initiative or on the petition of any 
interested person, pursuant to part 10 of this chapter. Prior to 
issuance of such a proposal, the applicant will be provided an 
opportunity for a conference with representatives of the Food and Drug 
Administration. When appropriate, investigators or other individuals may 
be invited to participate in the conference. All requirements for 
special studies, records, and reports will be published in Sec.  
310.304.

[39 FR 11680, Mar. 29, 1974, as amended at 41 FR 4714, Jan. 25, 1976; 42 
FR 15674, Mar. 22, 1977]