JD Supra4m
Rethinking FDA’s Accelerated Approval Pathway: New Draft Guidances and Implications for Drug Companies
The U.S. Food and Drug Administration (FDA) recently issued two new guidance documents governing details of the Accelerated Approval ...
Healio8h
Decentralized clinical trials: FDA guidance and the ‘new modus operandi’
The COVID-19 pandemic forced investigators conducting clinical trials to use decentralized elements, such as telehealth, to ...
GlobalData on MSN8h
FDA protocol deviation guidance could go further
The US Food and Drug Administration has released draft guidance on protocol deviations, but experts say it could go further.
JD Supra3d
Navigating FDA from 2024 into 2025 Human Foods Program
FDA Restructures its Food Resources Although there were a number of significant new regulations, the most significant food ...