FDA Offers Workshop On Non-Inferiority Studies Of Antibacterial Drugs
This article was originally published in The Pink Sheet Daily
How to set the margins in non-inferiority studies of new antibacterial drugs is the hard question the workshop will tackle.
You may also be interested in...
Industry is questioning the fundamental statistical underpinnings of FDA's approval pathways for antibiotics even as the agency prepares to roll out several guidances to help clarify them
FDA’s eagerly awaited draft guidance on non-inferiority trials should facilitate greater, and easier, use of such trials. It even allows for the possibility of using a non-inferiority design for a single supportive pivotal trial, especially if the trial uses a definitive endpoint like an outcomes assessment.
Biopharma firms developing drugs to treat community acquired pneumonia would be wise to follow the specifications FDA has set forth in a new 1draft guidance on the subject. The guidance specifies strict criteria for patient selection and confirmation of infection to support an evaluation based on noninferiority margins