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- 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…
- EFPIA urges EU lawmakers to further cut clinical trial approval timelines under Biotech ActThe European Federation of Pharmaceutical Industries and Associations (EFPIA) has asked EU legislators to go beyond the modest reductions in clinical trial approval times that are currently being c…