beeldscherm schreef op 7 december 2018 14:58:
FDA will allow observational studies as part of a push for real world evidence, new framework says
The FDA on Thursday unveiled a new framework discussing how the agency will use real-world evidence (RWE) and real-world data (RWD) to help companies win new indications for approved drugs and biologics, expand labels or satisfy post-approval study requirements.
Specifically, the agency says its program will evaluate the use of RWE to support changes to labeling about drug product effectiveness, including adding or modifying an indication, such as a change in dose, dose regimen or route of administration; new populations; or the addition of comparative effectiveness or safety information
endpts.com/fda-will-allow-observation...dat ze dan maar direct gebruik maken van de uitkomst van Pharmings bericht.......