US agency’s advisory committee will weigh the pros and cons of five possible development and regulatory pathways, with a specific focus on animal models.
The US FDA is calling on its Antimicrobial Drugs Advisory Committee to assess the potential use of five different development and regulatory pathways for antibacterial drugs targeting a single species of bacteria.
Sponsors have expressed interest in developing antibacterial drugs and monoclonal antibodies with activity against a single bacterial species that infrequently...
The European Medicines Agency has revised the sponsor handbook for the Clinical Trials Information System, bringing together guidance that was previously scattered across multiple platforms and documents to help sponsors navigate the trial process more efficiently.
The long-time industry executive led several drug approvals but may have a lot to learn about the intimate details of application review and the Center for Drug Evaluation and Research.
The US FDA's Psychopharmacology Advisory Committee emphasized high standards over regulatory flexibility while turning down Otsuka's brexpiprazole plus serotonin for post-traumatic stress disorder based on conflicting Phase III trials and post-hoc Phase II analyses.
