If a clinical trial concerns

If a clinical trial concerns a new regulated drug or medical device (or an existing drug for a new purpose), the appropriate regulatory agency for each country where the sponsor wishes to sell the drug or device is supposed to review all study data before allowing the drug/device to proceed to the next phase, or to be marketed. However, if the sponsor withholds negative data, or misrepresents data it has acquired from clinical trials, the regulatory agency may make the wrong decision. However, if leaders of the regulatory agency are friendly to industry, they may pressure staff scientists to make decisions favorable to industry, disregard their findings, or make it otherwise difficult for them to do their job.