FDA management - quick, lets do somthing!

U.S. regulators are re-evaluating clinical trials for medicines and plan changes that include a proposal to force drugmakers to promptly inform them if companies believe a researcher has committed fraud during a study.

The Food and Drug Administration is expected to launch an effort to standardize the forms used to collect information in studies and adjust the rules on how patients access experimental treatments, The Wall Street Journal said.

The FDA also will seek to clarify which adverse events in trials have to be reported to review boards that monitor studies to protect patients, the newspaper said.

FDA Deputy Commissioner Janet Woodcock will discuss the initiative on Wednesday at an industry conference.

Insider's view: about time!

This particular knee jerk comes hot on the heels of the Ketek affair and study 3014!

Dont get me wrong. The FDA is full of good people. In fact, it's an organisation of lions led by donkeys!