The US Food and Drug Administration (FDA) has released new draft guidance on developing drugs for pulmonary tuberculosis.
FDA’s latest draft guidance is intended to update the agency’s 2013 draft guidance with the same name, which was never finalized. “Since the 2013 final guidance was issued, there have been improvements in nonclinical models and further interest in streamlined clinical development programs as well as consideration for combination regimens with treatment-shortening regimens with improved safety and efficacy,” FDA wrote in a Federal Register notice.
In the new draft guidance, there is a new focus on nonclinical models, design considerations for early phase trials and a discussion on using superiority and non-inferiority as efficacy endpoints. There are also updates for including pediatric patients in trials as well as considerations for labeling, endpoints and safety in trials…
