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- FDA says MDUFA VI will prioritize review consistency and domestic focus over faster timelinesFDA officials explained that the next Medical Device User Fee Amendments, known as MDUFA VI, will aim to improve consistency in the review process. The agency said the new framework will emphasize…
- EMA launches consultation to streamline nonclinical development for life-threatening diseasesEMA announced a public consultation on proposals to accelerate the nonclinical phase of drug development for diseases that are severely debilitating or life‑threatening. The agency aims to reduce…