[Code of Federal Regulations]

[Title 21, Volume 1]

[Revised as of April 1, 2006]

From the U.S. Government Printing Office via GPO Access

[CITE: 21CFR99.305]



[Page 451-452]

 

                        TITLE 21--FOOD AND DRUGS

 

CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 

                                SERVICES

 

PART 99_DISSEMINATION OF INFORMATION ON UNAPPROVED/NEW USES FOR MARKETED 

DRUGS, BIOLOGICS, AND DEVICES--Table of Contents

 

     Subpart D_FDA Action on Submissions, Requests, and Applications

 

Sec.  99.305  Exemption from the requirement to file a supplemental 

application.



    (a) Within 60 days after receipt of an application for an exemption 

from the requirement of a supplemental application, FDA shall approve or 

deny the application.

    (1) If FDA does not act on the application for an exemption within 

the 60-day period, the application for an exemption shall be deemed to 

be approved.

    (2) If an application for an exemption is deemed to be approved, FDA 

may, at any time, terminate such approval if it determines that the 

requirements for



[[Page 452]]



granting an exemption have not been met. FDA shall notify the 

manufacturer if the approval is terminated.

    (b) In reviewing an application for an exemption, FDA shall consider 

the materials submitted by the manufacturer and may consider any other 

appropriate information, including, but not limited to, any pending or 

previously approved applications for exemption submitted by the 

manufacturer.

    (c) FDA may grant an application for an exemption if FDA determines 

that:

    (1) It would be economically prohibitive for the manufacturer to 

incur the costs necessary to submit a supplemental application for a new 

use, which at a minimum requires:

    (i) That existing data characterizing the safety and effectiveness 

of the drug or device, including data from the study described in the 

information to be disseminated are not adequate to support the 

submission of a supplemental application for the new use; and

    (ii) That the cost of the study or studies for the new use 

reasonably exceeds the expected revenue from the new use minus the cost 

of goods sold and marketing and administrative expenses attributable to 

the new use of the product, and there are not less expensive ways to 

obtain the needed information; or

    (2) It would be unethical to conduct clinical studies needed to 

support the submission of a supplemental application for the new use 

because:

    (i) Existing data characterizing the safety and effectiveness of the 

drug or device, including data from the study described in the 

information to be disseminated are not adequate to support the 

submission of a supplemental application for the new use; and

    (ii) Although available evidence would not support the submission of 

a supplemental application for the new use, the data are persuasive to 

the extent that withholding the drug or device in a controlled study 

would pose an unreasonable risk of harm to human subjects and no studies 

in different populations or of modified design can be utilized. In 

determining whether it would be unethical to conduct clinical studies, 

the agency shall consider, in addition to the persuasiveness of 

available evidence of effectiveness, whether the new use of the drug or 

device is broadly accepted as current standard medical treatment or 

therapy.