Agency could not have approved the application or
supplement without relying on that investigation. Thus, the investigation is not essential to the approval if 1) no
clinical investigation is necessary to support the supplement or application in
light of previously approved applications (.e., information other than clinical
trials, such as bioavailability data, would be sufficient to provide a basis
for approval as an ANDA or 505(b) (2) application because of what is already
known about a previously approved product), or 2) there are published reports
of studies (other than those conducted or sponsored by the applicant) or other
publicly available data that independently would have been sufficient to
support approval of the application, without reference to the clinical
investigation submitted in the application.
For
the purposes of this section, studies comparing two products with the same
ingredient(s) are considered to be bioavailability studies.
(a)
In
light of previously approved applications, is a clinical investigation (either
conducted by the applicant or available from some other source, including the
published literature) necessary to support approval of the application or
supplement?
YES
/___/ NO /___/
If “no,” state the basis for
your conclusion that a clinical trial is not necessary for approval AND GO
DIRECTLY TO SIGNATURE BLOCK ON Page 9:
(b)
Did
the applicant submit a list of published studies relevant to the safety and
effectiveness of this drug product and a statement that the publicly available
data would not independently support approval of the application?
YES
/___/ NO /___/
(1)
If
the answer to 2(b) is “yes,” do you personally know of any reason to disagree
with the applicant’s conclusion? If not
applicable, answer NO.
YES
/___/ NO /___/
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