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Congress' Year-End Appropriations Package Brings FDA Legislative Changes, Leaves Unresolved Policy Issues | Akin Gump Strauss Hauer & Feld LLP

In a break with past precedent, last yearโ€™s Food and Drug Administration (FDA) user fee reauthorization legislation did not contain significant FDA policy changes. Although the Senate...
United States Akin Gump Strauss Hauer Feld Rare Disease Endpoint Advancement Pilot Program Device Manufacturer Communications With Payors Drug Administration Pharmaceuticals For Children

Congress Year-End Legislative Package Delivers for the Rare Community

These measures follow the successful passage of H.R. 6833 in October, which included a five-year reauthorization of critical FDA user-fee programs that help ensure rare disease patients gain timely access to essential therapies and diagnostic tools.
United States Peter Saltonstall National Organization For Rare Disorders National Institutes Of Health Children Health Insurance Program Drug Administration

FDA Grants $38 Million To Fund Rare Disease Research | MedTruth - Prescription Drug & Medical Device Safety

The fund will back clinical trials, natural history studies, and regulatory science tools that will give the FDA a greater understanding of the ways that rare diseases can be treated.
Robertm Califf National Institute Of Health Rare Neurodegenerative Disease Grant Program Drug Administration Products Grants Program Accelerating Access

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