Rare Disease Improvements Planned Soon, And Up To Five Years From Now
FDA has short- and long-term plans to improve its rare disease program under PDUFA V, and next month the agency will continue its efforts to boost drug development in the sector.
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FDA’s Center for Drug Evaluation and Research plans to publish more than 50 new and revised draft guidances this calendar year.
Agency's Advisory Committee for Pharmaceutical Science and Clinical Pharmacology will be asked to weigh pre-approval data requirements and discuss innovative approaches to boosting drug development for rare diseases at its March 2 meeting.
Industry and other federal agencies could end up helping fund Commissioner Margaret Hamburg’s Regulatory Science Initiative, as FDA searches for money outside the appropriations process.