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September
23 & 24, 2010
DJA
to Speak and
Exhibit at the
2010 Contract
Pharma Conference
We
are happy to announce
that Damaris
DeGraft-Johnson,
President of DJA
Global Pharmaceuticals
Inc., will be speaking
at the upcoming
Contract Pharma 2010
Contracting and
Outsourcing Conference
and Tabletop
Exhibition in New
Brunswick, New
Jersey. She will
be speaking on the
topic Quality/Toxicology:
Strategic
Considerations When
Doing Due Diligence.
In addition, DJA will
be exhibiting. Please
stop by and visit our
table. We would be
delighted to speak
with you.
If
you would like more
info about the
upcoming conference,
please view the
conference schedule on
the
Contract
Pharma conference
website.
April
8 & 27, 2010
How
to Navigate the
FDA Regulatory
Maze to Drug
Approval in the
U.S.
Harriette Nadler to
present a webinar via
ExpertBriefings.com
that will provide a
legal and regulatory
framework for approval
of new drug
applications
[505(b)(1), 505(b)(2)
NDAs] and abbreviated
New Drug Applications
[505(j) ANDAs]. She
will provide
particular detail on
the 505(b)(2)
registration route
because this route is
less understood and is
a very practical way
forward with FDA,
especially for smaller
firms.
Click
here for a preview
To
sign up or for more
information, please go
to
ExpertBriefings.com.
November
2, 2009
Demystifying
FDA's 505(b)(2)
Drug Registration
Process
by
Harriette L. Nadler,
PhD and Damaris
DeGraft-Johnson, RPh,
MSc
Published in the
October 2009 issue of
the RAPS magazine, Regulatory
Focus, and
written by DJA's
president Damaris
DeGraft-Johnson and
Vice President
Harriette Nadler, the
article "Demystifying
FDA's 505(b)(2) Drug
Registration Process"
provides an overview
of the 505(b)(2)
process in comparison
to the other
registration
processes.
Please
download
a copy.
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