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BIO Comments on FDA Draft Guidance on Rare Diseases: Early Drug Development and the Role of Pre-IND Meetings

December 17, 2018

BIO submitted comments on the Food and Drug Administration’s (FDA) Draft Guidance, Rare Diseases: Early Drug Development and the Role of Pre-IND Meetings, which FDA says is intended to assist sponsors of drug and biological products for rare diseases in planning and conducting more efficient and productive pre-investigational new drug application (pre-IND) meetings.

BIO applauds the FDA’s initiative to advance drug development and review for therapies to treat rare diseases. It’s estimated there are 7,000 identified rare diseases, but only 5% have an approved therapy. This guidance provides important information to drug developers to make the drug development process more consistent, transparent, and efficient. BIO provided general comments and line edits.

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BIO Letter Rare Diseases Early Drug Development And The Role Of PreIND Meetings FDA–2018-D-3268
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