A Short-Cut To Profits
The following text was taken from the Kiplinger Letter, Vol. 103, No. 10.
* “The Food and Drug Admin. is planning to revamp its drug approval process. The agency will now generally require only one clinical trial instead of two before OK’ing new pharmaceuticals, a major shift from the standard dating back to the 1950s, when the FDA first obtained authority to grant marketing authorizations. The move is intended to provide both greater clarity and shorter timelines for getting new drugs to market, which can sometimes take over a decade.
* In practice, many medicines already go through only one clinical trial before securing FDA approval, because of changes made by Congress in the 1990s that encouraged greater flexibility for drugs that addressed hard-to-treat conditions. In recent years the FDA approved 60% of first-of-a-kind drugs with a single study.”
* From the logo of the Common Sense Crusade: “Fast Won’t Be Cheap…Fast Won’t Be Good…Good Won’t Be Cheap”.
* From the book: Remaking America Is Up To You. The Future Is Outside The Box; page 7…”You do not have a process until it is definable, repeatable, and measurable.”
NO COMMON SENSE
ANALYZE THE EXAMPLE
* Which supports and barriers were in play?
* What were the dynamics?
* Who, or what, won the Tug-of-War?
* Discuss the outcome with your friends and family.
* Use Post #4 as a reference for the dynamics and relationships between supports and barriers.
