Regulatory Affairs

Half of EU Clinical Trial Results Are Not Reported

Despite EU requirements for clinical trials to report results to the EU Clinical Trials Register within a year of a trial’s completion, sponsors have only reported about half of them so far, BMJ reported Wednesday. Read More

FDA Offers Technical Specs and Considerations for ANDAs

The FDA issued guidance Wednesday recommending technical specifications and general considerations on how certain comparative clinical endpoint bioequivalence study data and skin adhesion and irritation/sensitization study data for ANDAs should be submitted using FDA-supported data standards. Read More