March 2023, FDA released draft guidance to provide sponsors recommendations that assist in the development of monoclonal antibodies (mAbs) and other therapeutic proteins that directly target viral proteins or host cell proteins mediating pathogenic mechanisms of...
FDA released new guidance considerations for the design and conduct of externally controlled trials for Drug and Biological products. This industry guidance provides recommendations to sponsors and investigators considering the use of externally controlled clinical...
FDA published new draft guidance for M13A Bioequivalence (BE) for Immediate-Release (IR) Solid Oral Dosage Forms. The guidelines provide recommendations for conducting BE studies during development and post-approval phases for orally administered IR solid oral dosage...
From Pharmaceutical Technology The world of clinical trials is changing. Technological advancement has made decentralised trials more appealing than ever. Stakeholders must move quickly to ensure they understand the driving forces and are able to adapt effectively....
