NDA Delays: Blindsided By Site Problems
This article was originally published in RPM Report
Executive Summary
The Food & Drug Administration is listening to Capitol Hill about clinical trial data. The agency knows that both critics and defenders of the drug industry want it to ensure the credibility and integrity of clinical trial sites. Sponsors face another source of NDA delays.
You may also be interested in...
Data Integrity and Antibiotic Clinical Trials: FDA, Industry Try Systemic Therapy
FDA's push to encourage development of new antibiotics requires getting past data integrity issues in the class. The agency's workshop on antibacterial clinical trials revealed a range of efforts aimed at better Good Clinical Practices compliance - and those efforts can just as easily be applied to other drug classes
Data Integrity and Antibiotic Clinical Trials: FDA, Industry Try Systemic Therapy
FDA's push to encourage development of new antibiotics requires getting past data integrity issues in the class. The agency's workshop on antibacterial clinical trials revealed a range of efforts aimed at better Good Clinical Practices compliance - and those efforts can just as easily be applied to other drug classes
Chart: Antibiotics: The Triumph Of Hope Over Experience?
Johnson & Johnson's swift exit from its collaboration with Basilea for Zevtera (ceftobiprole) is only the latest setback for the antibacterial field, which has had little success in producing NME approvals in recent years.