[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2007]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR99.305]
[Page 453-454]
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
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 454]]
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.
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