FDA reinforces the single pivotal trial pathway for new drug approvals: what does this mean for your drug development?
The US Food and Drug Administration (FDA) recently reaffirmed [...]
CDER establishes new ‘Center for real-World Evidence Innovation’
The FDA’s Center for Drug Evaluation and Research (CDER) [...]
FDA provides new guidance on conducting clinical trials with decentralised elements
Clinical studies have traditionally required participants to come to [...]
FDA takes key steps to establish Rare Disease Innovation Hub
After announcing plans for a Rare Disease Innovation Hub [...]
Revised Declaration of Helsinki adopted by the global medical community
The principles of Good Clinical Practice (GCP) are derived [...]
CDER releases annual ‘Accelerating Rare Disease Cures (ARC) Program’ report for 2024
The FDA’s Center For Drug Evaluation and Research (CDER) [...]
The FDA’s Project Optimus Initiative ~ expediting life-saving drugs to market without compromising on safety!
The Food and Drug Administration's (FDA) Project Optimus initiative, [...]