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Re: None

Wednesday, 09/05/2018 2:51:28 PM

Wednesday, September 05, 2018 2:51:28 PM

Post# of 21540
The main benefits of Orphan Drug Status:

- Marketing exclusivity for 7 years
- Protocol assistance offered by FDA
- Tax credits of 50% of the clinical drug testing cost awarded upon approval
- Research grants—FDA awarded approximately 75 grants in 2013
- Waiver of NDA/BLA application fee—this is a $2.2 million value


http://pharmaceuticalcommerce.com/opinion/common-misconceptions-about-the-orphan-drug-designation/ (see part 7)

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