For a difference to make a difference it must be a real difference. Keep this in mind when deciding how much of a difference in safety, efficacy or convenience will be necessary to receive regulatory approval and encourage physicians to use your product.
FDA based slogans include: Incompetence on your part does not constitute malfeasance on ours. Also, Failure to plan on your part does not constitute an emergency on ours.
It is artificial to describe inclusion and exclusion criteria as if they were two separate categories of criteria. The only difference between them is that one set of criteria is expressed in positive terms and the other in negative terms.
Bert Spilker, PhD, MD is an independent consultant who was most recently the Senior Vice President of Scientific and Regulatory Affairs for PhRMA. He is the founder of Bert Spilker & Associates (BS&A).
