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Since
the Israel trials are almost complete, I am sure that the
company is getting ready to submit an IND application for
injectable AVR118 for HIV salvage therapy patients. I believe
the goal will be to use the Israel data to support the IND and
possibly start US (FDA) testing at Phase II.
Pasted below is the FDA regulation that provides data on using
foreign studies to support a US FDA INDA. It appears that if the
study is properly conducted the FDA will accept the data.
Hopefully more news concerning this subject will be coming soon
and AVR118 can finally start its journey with the FDA clinical
trial process!
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH
AND HUMAN
SERVICES (CONTINUED)
PART 312--INVESTIGATIONAL NEW DRUG APPLICATION--Table of
Contents
Subpart F--Miscellaneous
Sec. 312.120 Foreign clinical studies not conducted under an
IND.
(a) Introduction. This section describes the criteria for
acceptance
by FDA of foreign clinical studies not conducted under an IND.
In
general, FDA accepts such studies provided they are well
designed, well
conducted, performed by qualified investigators, and conducted
in
accordance with ethical principles acceptable to the world
community.
Studies meeting these criteria may be utilized to support
clinical
investigations in the United States and/or marketing approval.
Marketing
approval of a new drug based solely on foreign clinical data is
governed
by Sec. 314.106.
(b) Data submissions. A sponsor who wishes to rely on a foreign
clinical study to support an IND or to support an application
for
marketing approval shall submit to FDA the following
information:
(1) A description of the investigator's qualifications;
(2) A description of the research facilities;
(3) A detailed summary of the protocol and results of the study,
and, should FDA request, case records maintained by the
investigator or
additional background data such as hospital or other
institutional
records;
(4) A description of the drug substance and drug product used in
the
study, including a description of components, formulation,
specifications, and bioavailability of the specific drug product
used in
the clinical study, if available; and
(5) If the study is intended to support the effectiveness of a
drug
product, information showing that the study is adequate and well
controlled under Sec. 314.126.
(c) Conformance with ethical principles. (1) Foreign clinical
research is required to have been conducted in accordance with
the
ethical principles stated in
[[Page 83]]
the ``Declaration of Helsinki'' (see paragraph (c)(4) of this
section)
or the laws and regulations of the country in which the research
was
conducted, whichever represents the greater protection of the
individual.
(2) For each foreign clinical study submitted under this
section,
the sponsor shall explain how the research conformed to the
ethical
principles contained in the ``Declaration of Helsinki'' or the
foreign
country's standards, whichever were used. If the foreign
country's
standards were used, the sponsor shall explain in detail how
those
standards differ from the ``Declaration of Helsinki'' and how
they offer
greater protection.
(3) When the research has been approved by an independent review
committee, the sponsor shall submit to FDA documentation of such
review
and approval, including the names and qualifications of the
members of
the committee. In this regard, a ``review committee'' means a
committee
composed of scientists and, where practicable, individuals who
are
otherwise qualified (e.g., other health professionals or
laymen). The
investigator may not vote on any aspect of the review of his or
her
protocol by a review committee.
(Voluntary Disclosure: Position- Long;
ST Rating- Hold; LT Rating- Hold)
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