JD Supra1d
CMS Proposes Guidance on Use of Real World Data for Coverage with Evidence Development
Real world data (RWD), which is data from actual patient treatments, provides valuable information on safety and effectiveness of innovative ...
JD Supra23d
FDA warns of “important” clinical trial protocol deviations
The U.S. Food and Drug Administration (FDA) published the draft guidance “Protocol Deviations for Clinical Investigations of Drugs, Biological Products, and Devices,” which provides advice for ...
GlobalData on MSN8d
FDA protocol deviation guidance could go further
The US Food and Drug Administration has released draft guidance on protocol deviations, but experts say it could go further.
FierceBiotech1mon
FDA draft guidance recommends tissue biopsies only be required in trials if necessary and low risk
Tissue biopsies can be important parts of testing new drugs, and the FDA has now issued a draft guidance with recommendations for when they should be included in clinical trial protocols.
Yahoo Finance8d
FDA protocol deviation guidance could go further
Protocol deviations ... The US Food and Drug Administration (FDA) released draft guidance in December 2024, with the agency urging sponsors, investigators, clinical research organisations (CROs ...