Orphan Drug Designation Application
Getting an orphan designation can be a challenge, and just the designation is not enough. You must get and translate that knowledge into regulatory and drug development efforts to really make a difference.
The Weinberg Group will thoroughly evaluate and examine all relevant documents, including product information, scientific articles, public-domain information, disease prevalence data, etc. in order to identify whether or not your drug qualifies as orphan. If we recommend proceeding with an Orphan Drug Designation application, we will build on the information we obtained to develop and submit the application, on your behalf, to the FDA’s Office of Orphan Product Development (OOPD). If your orphan drug application is approved, your product will enjoy:
- Seven years of marketing exclusivity.
- Protocol assistance.
- Tax credits covering up to 50 percent of clinical trial costs.
- Research grants to help fund clinical investigations for orphan products.
- Waiver of the PDUFA application fee.