At the dusk of the first decade of the 21st century, a new FDA emerges — one that, shaped by the new Obama administration, will strive to ethically approve drugs and devices while considering every possible significant adverse risk to the general public. Call it a lesson learned from putting the politics of fast-tracking at the hands of major third parties, namely Pharma, ahead of patient and public safety.

This notion is all too cognizant in the minds of the FDA panel, which is struggling with the approval of a new anti-diabetic drug (similar in function to this agent) which shows even greater promise as an adjunct in the early stages of treatment of the disorder. The problem? During the early phases of the drug’s R&D, the incidence of a certain type of thyroid tumor began to show up in rats. Consequently, the FDA is “seeking additional clinical data” (since rats aren’t exactly people). It’s certainly a prudent move, especially in a weak healthcare economy overall, in which the process of new drug development is occurring at a snail’s pace — a rate at which a new approval’s faults would invite extreme immediate  and well deserved post-market scrutiny. | LINK

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