Invivodata Presents Electronic Patient Diary To FDA; Role For Clinical Trials?
Executive Summary
FDA is exploring ways to incorporate electronic patient diaries into clinical trial designs
You may also be interested in...
Chronic Pain Standard Proposed By FDA Too Strict, Four Trials OK, Cmte Says
Global chronic pain can be an appropriate Rx analgesic indication, but the revised clinical trial requirements under consideration by FDA may be too stringent, Arthritis Advisory Committee members said
Part D Discount Liability Coming Into Focus: CMS Releases Drug Cost Data
Newly released Medicare Part D data sheds light on the sales hit that branded pharmaceutical manufacturers will face when the coverage gap discount program gets under way in 2011
FDA Skin Infections Guidance Spurs Debate On Endpoint Relevance
FDA appears headed for a showdown with clinicians and the pharmaceutical industry over the proposed new clinical trial endpoints for acute bacterial skin and skin structure infections, the guidance's approach for justifying a non-inferiority margin and proposed changes in the types of patients that should be enrolled in trials