MedCity News January 25, 2023
Jane Myles

The agency’s goal is to spur a macro shift in clinical trials. The FDA is trying to tell these companies what it wants to be different in trials across the board with regards to digital health endpoints, the use of real-world data (RWD) as regulatory-grade data, and diversity in clinical trial inclusion.

As we begin the new year, there is a lot of talk in the drug development world about Federal Drug Administration (FDA) guidance documents for clinical and decentralized clinical trials (DCTs). This chatter is understandable because we’re likely to see some emphasis put into previous documents that have not been rigidly enforced.

Unfortunately, a lot of trial sponsors aren’t thinking about these guidance documents in a holistic manner;...

Today's Sponsors

LEK
ZeOmega

Today's Sponsor

LEK

 
Topics: Clinical Trials, FDA, Govt Agencies, Trends
Listen: What the mifepristone case means, GLP-1 skepticism, & Chinese biotech
FDA approves Akebia anemia pill, two years after rejection
FDA Approves Winrevair, Merck’s Novel Treatment for Pulmonary Arterial Hypertension
FDA approves Merck drug for rare lung disorder
Neuronetics wins FDA clearance for device to treat adolescents with depression

Share This Article