According to an editorial published in the January edition of the British Medical Journal, researchers often do not report relevant clinical trial data. The editorialists said the problem is missing data, “We are not dealing here with trial design, hidden bias or...
FDA recently issued a warning letter to clinical investigator Betty Tuller, PhD, after she purportedly violated several requirements under 21 CFR Part 312 while working at Florida Atlantic University’s Center for Complex Systems and Brain Sciences. According to the...
The FDA will hold a 2 day public hearing to obtain input from those interested in FDA’s scope and direction in modernizing regulations, policies, and practices that apply to clinical trials of FDA-regulated products. Anyone interested is strongly encouraged to...
In February, FDA released a new guidance document entitled “Questions and Answers on Informed Consent Elements, 21 CFR § 50.25(c)”. The purpose of the guidance is to help small businesses, particularly clinical trial sponsors, investigators, and institutional review...
Margaret Anderson, the Executive Director of FasterCures, has released her top 10 medical research trends to watch in 2012. Her top 3 are listed below: NCATS: Who moved my cheese? FDA: The science of Failure Intellectual property: Keep it simple, stupid What are the...
