FDA to reduce regulatory red tape for biosimilars

The FDA on Wednesday published new draft guidance outlining how biosimilar developers can cut out Phase 3 comparative efficacy studies, potentially reducing development timelines and cutting costs.
The move, first disclosed by FDA Commissioner Marty …

Subscribe for Updates

Copyright 2025 dijee Intelligence Ltd.   dijee Intelligence Ltd. is a private limited company registered in England and Wales at Media House, Sopers Road, Cuffley, Hertfordshire, EN6 4RY, UK registeration number 16808844