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The FDA has released the details of its Orphan Drug Modernization Plan, developed to eliminate the existing orphan drug request backlog and create a system for timely response deadlines for all future requests. This plan will be one of several efforts as part of the agency’s encompassing Medical Innovation Development Plan.“People who suffer with rare diseases are too often faced with no, or limited, treatment options, and what treatment options they have may be quite expensive due in part to significant costs of developing therapies for smaller populations,” Scott Gottlieb, MD, FDA commissioner, said in a press release from the agency. “Congress gave us tools to incentivize the development of novel therapies for rare diseases and we intend to use these resources to their fullest extent in order to ensure Americans get the safe and effective medicines they need, and that the process for developing these innovations is as modern and efficient as possible.”
Original Article: FDA announces plan to eliminate orphan drug designation backlogNEXT ARTICLE
In order to become availible to pateints, drugs need to undergo a number of phases of clinical trials to test their efficacy and safty and to then be authorised by the drug approval organistion in each respective country. This is the FDA in the USA and N...
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