Description
<strong>Course Schedule - February 9-10, 2009</strong><br/><br/>Orphan Drugs, designed to treat or prevent diseases
affecting fewer than 200,000 persons, have a special FDA
status. Fees are waived; exclusivity protection is provided and
there is some additional flexibility in experimentation and
approval. Orphan Drug Status is awarded after agency
review of a submitted Orphan Drug Application.<br><br>
This two-day seminar provides<b> hands on guidance</b>, FDA
evaluation criteria and submissions checklists. Participants
who bring a planned submission topic to the course will
develop a comprehensive application outline over the two
days of the program.<br><br>
By the end of the course you will have a specific outline for
your regulatory submission.
01/13/2009
To
01/01/0001
Training Company
The Center for Professional Advancement (CfPA)
Industry
Clinical Research Organization
Course Category
Brochure Name
http://www.cfpa.com/PDF/2009/2223,C8-162,0902-203.pdf
Address
New Brunswick, NJ USA