FDA Food and Drug AdministrationHS hidradenitis suppurativaODA Orphan Drug Act of 1983US United StatesThe Orphan Drug Act of 1983 (ODA) put in place a set of financial and marketing incentives to stimulate the development of drugs to treat rare diseases, and since its passage, more than 600 ...
1983年1月4日美国国会通过的美国《罕见病药物法》(Orphan Drug Act)是根据《联邦食品药品和化妆品法》(Frederal Food…www.healthoo.com|基于30个网页 2. 罕见病药品法 通过《罕见病药品法》(ORPHAN DRUG ACT),使FDA能鼓励治疗罕见病(rare diseases)需要的药品的研究和上市。 198…www.fdc-intl.com|基于23个...
孤儿药具有研发难度大、成本高、目标市场小、获利能力差等特征,因此最初很多药企并不愿涉足该领域。 为了鼓励孤儿药的研发,FDA于1983年首先制定《孤儿药法案 》(Orphan Drug Act),并于1992年建立了加速审核程序,之后又推出了孤儿药审评的特殊待遇,如提供研发租税优惠、上市规费豁免、保障独占市场地位及政府研发补助...
HANGZHOU, Dec. 28 (Xinhua) -- A new type of Aptamer Drug Conjugate (ApDC) developed by a group of Chinese researchers has recently been granted orphan drug designation from the U.S. Food and Drug Administration (FDA), bringing new hope for patients with rare eye cancer, the Hangzhou Insti...
“The FDA’s orphan drug designation for felzartamab is an acknowledgment of the critical and ongoing unmet need in PMN and the potential for felzartamab to be an important new therapeutic option to improve the lives of patients with PMN who currently have ...
FDA Orphan Drug Designation is granted to investigational therapies addressing rare medical diseases or conditions that affect fewer than 200,000 people in the United States. Orphan Drug status provides benefits to drug developers, including assistance in the drug development process, tax credits for cl...
theFDAqualifies the sponsor for incentives provided for in the Orphan Drug Act, which can include protocol assistance for clinical trials, preion drug user fee waivers, tax incentives and seven years of market exclusivity. The granting of an orphan drug designation does not alter the standard ...
The US Food and Drug Administration (FDA) has granted orphan drug designation for Arcturus Therapeutics’ ARCT-032 for cystic fibrosis.
FDA Orphan Drug Designation is granted to investigational therapies addressing rare medical diseases or conditions that affect fewer than 200,000 people in the United States. Orphan Drug status provides benefits to drug developers, including assistance in the drug development process, tax credits for cl...
FDA Release: Sept. 4, 2012 The U.S. Food and Drug Administration today approved Bosulif (bosutinib) to treat chronic myelogenous leukemia (CML), a blood and bone marrow disease that usually affects older adults. An estimated 5,430 men and women will be diagnosed with CML in 2012. Most pe...