Preparing for and Holding Meetings with Regulatory Agencies Presenting science to the FDA is an art. –Jerry Halperin, former Food and Drug Administration executive and Food and Drug Law Institute…
Learning Which Regulatory Guidances and Standards May Be Modified The pessimist sees difficulty in every opportunity. The optimist sees the opportunity in every difficulty. –Winston Churchill Success is not achieved…
Introduction to Regulatory Affairs There are three kinds of people in all types of organizations—rowboat people, sailboat people, and steamboat people. Rowboat people need to be pushed or shoved along….
Negotiating and Interacting with Regulatory Agencies I cannot give you a sure-fire formula for success, but I can give you the formula for failure, which is: Try to please everybody….
The Concept of Normalcy Within Western medicine, physically ill people approach medical helpers in a manner much different from the psychologically ill. Physically ill people bring sick bodies to physicians;…
Recruiting and Training Clinical Investigators All truths are easy to understand once they are discovered; the point is to discover them. –Galileo Galilei (1564-1642). There are no such things as…
Introduction Just as in any sport where one is trying to score points, it does not matter how close you come to your goal, no amount of effort will achieve…
Registries and Directories of Clinical Trials, plus Disclosure of Their Results and Archiving Their Data In science the credit goes to the man who convinces the world, not the man…
Clinical Trials Come of Age My interest in science was always essentially limited to the study of principles … That I have published so little is due to this same…
Surrogate Endpoints and Biomarkers Science is facts. Just as houses are made of stones, so is science made of facts. But a pile of stones is not a house and…
