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 ...

The FDA announced that it removed a limitation on the use of real-world evidence (RWE) in drug and device application reviews ...

The FDA said it plans to accept new forms of real-world evidence in product applications, starting with a subset of medical ...

Pharma and biotech companies have access to an unprecedented variety of health data, from electronic health records and ...

Angela Jia, MD, PhD, is a radiation oncologist specializing in stereotactic body radiation therapy (SBRT), adaptive radiotherapy, and clinical trials focused on prostate, bladder, and kidney cancers.

CorMedix Therapeutics (Nasdaq: CRMD), a biopharmaceutical company focused on developing and commercializing therapeutic products for life-threatening diseases and conditions, today announced interim ...

Real-world data is invaluable to healthcare tech developers. This type of data reflects actual patient experiences, treatments and outcomes in diverse, real-world environments — rather than controlled ...

The fight against cancer is complex and multifaceted, requiring a collective effort to create transformative change. There is a vast opportunity for collaboration to spark discussions and advance ...

The US FDA will no longer require that identifiable individual patient data be required from applicants when submitting ...

FOSTER CITY, Calif.--(BUSINESS WIRE)-- Gilead Sciences, Inc. (Nasdaq: GILD) today announced the upcoming presentation of new clinical data and real-world evidence (RWE) from its antiviral research and ...

Recurrent early pregnancy loss (REPL) has long been marked by uncertainty, limited evidence, and treatments that offered hope ...