We have GCPs, GLPs, GMPs and others. We theoretically have GRRPs (Good Regulatory Review Practices)but the industry and public need to know that they are published and are being followed. How about an annual audit system conducted by GAO--and a comparable group in other countries?

Why is it that the systems for appealing the FDA's decisions and those of other regulatory agencies are so limited and fraught with repercussions? More oversight and accountability for the quality and rationality of their decisions is needed.

Ensure that at the end of every regulatory agency meeting the company summarizes all points of agreement and all action points for each side to conduct. If the agency makes this summary, ensure that it is complete and that all of their statements are acceptable.

Provide a copy of the company's minutes of every regulatory meeting to the agency within one week to assist them in preparing their own minutes, and to ensure that they have considered all of the points you have made.

There is an art to slide management in terms of design and content, and in the indexing of slides in complex and/or long presentations, particularly when backup slides need to be called up virtually instantly (e.g., at FDA Advisory Committee Meetings).

The golden rule about inclusion criteria for clinical trials is to use the minimum number necessary and with the least restrictive ranges possible. Start every protocol without any inclusion criteria, even if 50 trials have previously been done on the product and determine which ones are essential. Each one restricts the potential available pool of patients you can enroll.

Using minimally acceptable criteria for continuing with a product's development facilitates the best business decisions and helps to avoid games being played on prematurely terminating a viable project or prolonging a dying or even dead project.

I have not failed. I've just found 10,000 ways that won't work. Thomas Edison.

In the field of observation, chance favors only the prepared mind. Louis Pasteur

An investigator who is not enthusiastic at the outset of a project will almost never be enthusiastic at the end of it.

If your company's staff are not 100% excellent, decide how you can attract and retain better staff.

Are the company's managers mainly living in the past, present or future? How many are in the present and keeping an eye on the future while planning how to get there? Where are you living?