Regulatory Applications for Marketing Approval and Global Interactions with Regulators Don’t be pushed by your problems, be led by your dreams. –Anonymous The processes and procedures for applying for regulatory…
Introduction The fact is, everyone is in sales. Whatever area you work in, you do have clients and you do need to sell. –Jay Abraham No matter what your product…
Regulatory Strategies in Real-life Product Development Statistical significance does not always mean clinical significance; clinical significance does not always mean significance for medical practice. –Bert Spilker One of the tests…
Food and Drug Administration Advisory Committee Meetings To be sure, it is not the fruits of scientific research that elevate a man and enrich his nature, but the urge to…
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…
