MedTech Intelligence

FDA Publishes New Set of Real-World Evidence Examples

New set of 73 Real World Evidence examples illustrate how RWD can support rigorous validation of novel device software ...
BioSpace

FDA Reversals in Rare Disease Space Highlight Confusion Around External Controls

While recent FDA guidance speaks to the agency’s support of innovative trial designs—including the use of external ...
Applied Clinical Trials Online

What Real-World Data Shows About Current Cancer Care

C.K Wang, MD General Manager of Oncology & Chief Medical Officer Verana Health C.K. Wang is the General Manager of Oncology ...
The American Journal of Managed Care

FDA to Accept Deidentified Real-World Evidence for Select Medical Device Applications

The FDA now accepts RWE for device submissions without needing identifiable patient data, facilitating the use of large, de-identified databases. This change addresses previous limitations that ...
BioSpace

Rare Disease Leaders Call for Regulatory Clarity as FDA Balances Urgency With Rigor

With CBER director Vinay Prasad set to depart the agency at the end of the month, a coalition of patient groups and biotech ...