BIO Comments on FDA Draft Guidance on Rare Diseases: Early Drug Development and the Role of Pre-IND Meetings
BIO submitted comments on the Food and Drug Administration’s (FDA) Draft Guidance, Rare Diseases: Early Drug Development and the Role of Pre-IND Meetings, which FDA says is intended to assist sponsors of drug and biological products for rare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.