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- Study Finds Accelerated Approval Rarely Used for Adult Cancer Drugs Over Past 20 YearsA new analysis published in JAMA shows that most adult oncology medicines approved by the FDA in the last two decades received standard approvals for expanded uses, relying on surrogate endpoints r…
- FDA releases FY 2027 user fee rates and updates guidance for injectable peptide ANDAsThe U.S. Food and Drug Administration has published its user fee rates for fiscal year 2027, covering prescription drugs, generics, biosimilars, medical devices and over‑the‑counter products. The r…