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- FDA releases FY 2027 user fee rates for prescription, generic, biosimilar, device and over the counter programsThe U.S. Food and Drug Administration has published its user fee schedule for fiscal year 2027. The rates cover prescription drugs, generic drugs, biosimilars, medical devices and over the counter…
- FDA releases updated guidances for injectable peptide drugs and announces FY 2027 user fee ratesThe FDA has updated 17 draft product-specific guidances aimed at helping sponsors prepare abbreviated new drug applications for injectable peptide products. The guidances cover peptide therapies u…