Real World Data and Real World Evidence to Support Regulatory Decision Making for Drug and Biological Products – FDA Draft Guidance
Use of Real-World Data (RWD) and Real-World Evidence (RWE) in Regulatory Decisions.
The FDA issued this draft guidance as part of its Real-World Evidence (RWE) Program to help fulfill requirements...
Drug and Biological Products, FDA Draft Guidance, Real-World Data, Real-World Evidence