|
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.
|
