The U.S. Food and Drug Administration (FDA) issued this week three guidance documents related to clinical trials: a draft guidance on multiregional trials in oncology, a draft guidance on integrating randomized controlled...more
The U.S. Food and Drug Administration (FDA) has just published a highly-anticipated draft guidance on the implementation of decentralized clinical trials (DCTs) for drugs, biologics, and medical devices. In the draft...more
Companies in the life sciences and health care industry, like most companies, navigated unparalleled challenges in 2020. But unlike other industries, they had to do so while simultaneously facing the biggest challenge of all...more
This month, the U.S. Food and Drug Administration (FDA or the agency) issued a final guidance on live case presentations as part of clinical trials conducted under an approved (or conditionally approved) investigational...more
7/26/2019
/ Clinical Trials ,
Food and Drug Administration (FDA) ,
Investigational Device Exemptions ,
IRB ,
Life Sciences ,
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Medical Research ,
New Guidance ,
Pharmaceutical Industry ,
Regulatory Oversight ,
Regulatory Requirements ,
Reviewability Determinations