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Regulatory compliance focus: getting new drugs to market

Principals in some industries and business realms simply have to deal with the reality that the products and/or services they offer will always be targeted for heightened scrutiny by state and federal regulators.

Take actors in the aeronautics industry, for example. For obvious reasons, a new airplane process or feature will be thoroughly vetted and repeatedly tested -- to an exhausting degree -- before it is approved for use on commercial flights.

And, of course, similar and exacting safeguards extend to new product offerings in automobiles, medical devices and testing equipment, and next-step advances in the military and aerospace industry.

Pharmaceutical companies that develop and bring new drugs to the marketplace can also point to their singular realm as being an obvious target for deep probing from safety regulators, as well. Regulatory compliance is a top-tier focal point throughout the process of drug development and ultimate FDA approval (or rejection).

A recent news focus on the subject readily bears that out, with a wide panoply of competing views regarding the FDA's approval role being on display.

Here's one: The new presidential administration thinks approval is an overly slow and laborious process. President Trump vows to speed it up.

And here's another: If anything, the nation's preeminent health regulating agency gives the go-ahead nod to many drug offerings too quickly, thus endangering the public.

And, of course, there is a middle-of-the-road position, which is espoused by myriad commentators who currently play -- as well as formerly assumed -- a prominent role within the FDA. They say that the agency process for evaluating and ultimately weighing in with yes-or-no ultimatums on new drugs is likely the best that exists globally and one that quite adequately balances the need to get new drugs to the marketplace with the public's due concern for safety.

It is uncertain how all those views will eventually be sorted out, especially given the current administration's insistence that the process be expedited going forward.

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