FDAnews Announces — The Inside Track to Orphan Drug Designation Webinar, Aug. 2, 2016

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Manufacturers seeking orphan designation for their latest drug want and need the benefits that come with the designation. A bit of insider knowledge might come in handy because last year only 480 applications out of 566 received orphan designation.

The Inside Track to Orphan Drug Designation
**An FDAnews Webinar**
Aug. 2, 2016 — 1:30 p.m. – 3:00 p.m. ET
http://www.fdanews.com/insidetrackorphandrugdesignation

Manufacturers seeking orphan designation for their latest drug want and need the benefits that come with the designation.

A bit of insider knowledge might come in handy because last year only 480 applications out of 566 received orphan designation.

What steps can manufacturers take so they’re not caught short in the application?

Who has better insider experience than the man who implemented the Orphan Drug Act? Dr. Timothy Coté, former Director of the FDA Office of Orphan Products Development (OOPD), will explain the ins and outs of obtaining orphan drug status in a 90-minute webinar on Aug. 2.

After attending this webinar attendees will be able to:

  • Create a compelling regulatory submission customized to the business strategy and the FDA’s unwritten rules that only insiders fully understand
  • Know the best time to apply to OOPD to gain approval for a submission
  • Understand why obtaining approval for orphan drugs is inherently different from non-orphan drugs
  • Detail prevalent criteria for orphans that meets agency requirements
  • Explain in regulatory sufficient terms the clinical superiority in orphan drug designation
  • Develop a world-class game plan for comprehensive FDA approval, enabling manufacturers to obtain:

o seven years of marketing exclusivity
o tax credits
o PDUFA fee exemption
o regulatory support from OOPD
o investment community interest
o access to OOPD’s grants program

Register today and learn how to obtain orphan drug designation from an industry insider.

Meet the Presenter:
Dr. Timothy R. Coté, Principal & Chief Executive Officer, Coté Orphan

Dr. Coté is a leading national regulatory expert in orphan drug development. With 23 years of Federal experience at the FDA, NIH, and CDC, Dr. Coté recently served as the Director of the FDA Office of Orphan Products Development (OOPD) from Sept. 2007 – May 2011. In this role he implemented the Orphan Drug Act and personally signed decisions on 1400+ orphan drug designation applications.

Who Will Benefit:

  • Regulatory Affairs
  • Quality Assurance
  • Medical Director
  • Submission and applications specialist
  • Strategic planning and lifecycle management specialists
  • Executive management
  • General/corporate counsel
  • Regulatory professionals
  • Consultants/service providers

Webinar Details:
The Inside Track to Orphan Drug Designation
**An FDAnews Webinar**
Aug. 2, 2016 — 1:30 p.m. – 3:00 p.m. ET
http://www.fdanews.com/insidetrackorphandrugdesignation

Tuition: $287 per site

Easy Ways to Register:
Online: http://www.fdanews.com/insidetrackorphandrugdesignation            
By phone: 888-838-5578 or 703-538-7600

About FDAnews:
FDAnews is the premier provider of domestic and international regulatory, legislative, and business news and information for executives in industries regulated by the US FDA and the European Medicines Agency. Pharmaceutical and medical device professionals rely on FDAnews' print and electronic newsletters, books and conferences to stay in compliance with international standards and the FDA's complex and ever-changing regulations.

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Michelle Butler
FDANEWS
+1 (703) 538-7665
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