Ocugen Receives Fourth FDA Orphan Drug Designation for the Same Product, OCU400 (AAV-NR2E3) Gene Therapy, for the Treatment of Another Key Inherited Retinal Disease (IRD), PDE6B Gene Mutation-Associated Retinal Diseases
The FDA Office of Orphan Products Development grants orphan designation for novel drugs or biologics that treat a rare disease or condition affecting fewer than 200,000 patients in the U.S. Orphan designation qualifies the sponsor of the drug for various development incentives of the Orphan Drug Act, including a seven-year period of U.S. marketing exclusivity, tax credits for clinical research costs, clinical research trial design assistance, the ability to apply for annual grant funding and waiver of Prescription Drug User Fee Act filing fees.
finance.yahoo.com/news/ocugen-receives-fourth-fda-orphan-113000525.html?guce_referrer=aHR0cHM6Ly9maW52aXouY29tL3F1b3RlLmFzaHg_dD1PQ0dOJnR5PWMmcD1kJmI9MQ&guce_referrer_sig=AQAAABgPTrus2tikTu4gxp57js4lEzxFriibzok1faK2BfMeAbIxMwPE9kRSSK5kW0d1LPawPStFJ4EtKUyk_J4eqQSsT2MkRade1ZSIGeoj76TWjDRyp1oKdy1T_3MgaqkSvawox07yR9_sEsO14MpNOu7sQNZYWnAVc_A6Z8uO3MjH&_guc_consent_skip=1597143160
The FDA Office of Orphan Products Development grants orphan designation for novel drugs or biologics that treat a rare disease or condition affecting fewer than 200,000 patients in the U.S. Orphan designation qualifies the sponsor of the drug for various development incentives of the Orphan Drug Act, including a seven-year period of U.S. marketing exclusivity, tax credits for clinical research costs, clinical research trial design assistance, the ability to apply for annual grant funding and waiver of Prescription Drug User Fee Act filing fees.
finance.yahoo.com/news/ocugen-receives-fourth-fda-orphan-113000525.html?guce_referrer=aHR0cHM6Ly9maW52aXouY29tL3F1b3RlLmFzaHg_dD1PQ0dOJnR5PWMmcD1kJmI9MQ&guce_referrer_sig=AQAAABgPTrus2tikTu4gxp57js4lEzxFriibzok1faK2BfMeAbIxMwPE9kRSSK5kW0d1LPawPStFJ4EtKUyk_J4eqQSsT2MkRade1ZSIGeoj76TWjDRyp1oKdy1T_3MgaqkSvawox07yR9_sEsO14MpNOu7sQNZYWnAVc_A6Z8uO3MjH&_guc_consent_skip=1597143160
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The information and publications are not meant to be, and do not constitute, financial, investment, trading, or other types of advice or recommendations supplied or endorsed by TradingView. Read more in the Terms of Use.