[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: 21CFR99.303]
[Page 453]
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. 99.303 Extension of time for completing planned studies.
(a) Upon review of a drug or device manufacturer's proposed
protocols and schedules for conducting studies needed for the submission
of a supplemental application for a new use, FDA may, with or without a
request for an extension from the manufacturer, determine that such
studies cannot be completed and submitted within 36 months. The agency
may exercise its discretion in extending the time period for completing
the studies and submitting a supplemental application. Extensions under
this paragraph are not subject to any time limit, but shall be made
before the manufacturer begins the studies needed for the submission of
a supplemental application for the new use.
(b) The manufacturer may, after beginning the studies needed for the
submission of a supplemental application for a new use, request in
writing that FDA extend the time period for conducting studies needed
for the submission of a supplemental application for a new use and
submitting a supplemental application to FDA. FDA may grant or deny the
request or, after consulting the manufacturer, grant an extension
different from that requested by the manufacturer. FDA may grant a
manufacturer's request for an extension if FDA determines that the
manufacturer has acted with due diligence to conduct the studies needed
for the submission of a supplemental application for a new use and to
submit such a supplemental application to FDA in a timely manner and
that, despite such actions, the manufacturer needs additional time to
complete the studies and submit the supplemental application. Extensions
under this paragraph shall not exceed 24 months.
(c) If FDA extends the time period for completing the studies and
submitting a supplemental application under paragraph (a) of this
section after the manufacturer has submitted a certification under Sec.
99.201(a)(4)(ii)(B), or if FDA grants a manufacturer's request for an
extension under paragraph (b) of this section, the manufacturer shall
submit a new certification under Sec. 99.201(a)(4)(ii)(B) that sets
forth the timeframe within which clinical studies will be completed and
a supplemental application will be submitted to FDA.
Back to Top
© 2007 Betterchem Corp.
|
