Podcast: Non-binding Guidance: Real-World Evidence in Drug Development and FDA Submissions
The U.S. Food and Drug Administration (FDA) recently published its criteria for reporting on the use of real-world evidence (RWE) in drug and biologic submissions, as part of its commitments under the Prescription Drug User...more
The Food and Drug Administration (“FDA” or the “Agency”) user fee negotiations may have hit an iceberg, but it did not sink all the legislative riders that accompanied this summer’s House and Senate bills. Buried within the...more