FDA announces Draft Guidance on Rare Diseases: Early Drug Development and the Role of Pre-Investigational New Drug Application Meetings - Drug Information Update

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The U.S. Food and Drug Administration (FDA) issued a draft guidance that aims to bring more clarity to the drug development process as it relates to rare diseases. This guidance, “Rare Diseases: Early Drug Development and the Role of Pre-Investigational New Drug Application Meetings” will assist sponsors of drug and biological products for the treatment of rare diseases in conducting more efficient and productive pre-investigational new drug application (pre-IND) meetings. Early, and well planned, exchanges between FDA staff and product developers streamline the review process and help FDA make informed regulatory decisions in the fastest manner possible. The FDA looks forward to receiving public comment on this guidance through the established docket (Docket Number FDA-2018-D-3268).