I attended a session at the 2008 BIO convention in San Diego celebrating the 25th anniversary of the Orphan Drug Act. Before the Act, there were almost no orphan drugs. The exemption from the PDUFA user fees (running $1.175MM today), 50% tax credit for clinical studies and a 7 year marketing exclusivity are powerful incentives to develop these drugs. Tim CotÃ©, Division Director, noted that the Agency has about $14MM ijn grants per year and has not used up the money. Time to write your grant and get free government money!
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