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DJA News Archive

 
 

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.

   

DJA Global Pharmaceuticals, Inc. is focused on bridging the complex areas of pharmaceutical development and global regulatory science.  DJA was founded to provide sound, practical guidance to the pharmaceutical, device, and biotechnology industries.

 
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