Trial Registry Bill Should Request Protocol With Results, FDA’s Temple Says
Executive Summary
Any proposal to expand the ClinicalTrials.gov registry that does not require submission of trial protocols "does not do the whole job," FDA Office of Medical Policy Director Robert Temple said at a June 19 session of the Drug Information Association in Atlanta
You may also be interested in...
Negative Antidepressant Trial Results See Low Publication Rate, Study Finds
The vast majority of antidepressant clinical trials viewed by FDA as having negative or questionable results are either not published in medical journals or published in a way that conveys a positive outcome, according to results of a study published in the January 17 issue of the New England Journal of Medicine
Negative Antidepressant Trial Results See Low Publication Rate, Study Finds
The vast majority of antidepressant clinical trials viewed by FDA as having negative or questionable results are either not published in medical journals or published in a way that conveys a positive outcome, according to results of a study published in the January 17 issue of the New England Journal of Medicine
FDA Bill Passes; Congress Adds $225 Million To Industry User Fee Burden
Final FDA reform legislation that cleared Congress adds an additional $225 million to industry's user fee tab over five years, but limits penalties that FDA can assess to enforce its new authorities to mandate labeling changes and postmarket studies