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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Draft Guidances For 2013 Will Grapple With Biosimilars, Track and Trace, Compounding
FDA’s Center for Drug Evaluation and Research plans to publish more than 50 new and revised draft guidances this calendar year.
Orphan Drug Safety: FDA Asks How Much Pre-Approval Data Is Enough?
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.
With Federal Dollars Scarce, FDA May Fundraise For Regulatory Science Initiative
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.