Orphan Drug Application and Submission Training Course :

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.