nos-trum. pronunciation: \nos'-trum\. noun. Etymology: Latin, neuter of noster our, ours.
1. a medicine of secret composition recommended by its preparer but usually without scientific proof of its effectiveness.
2. a usually questionable remedy or scheme.
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Tuesday, February 15, 2011

STUDY: Medical Devices That Are Approved Quickly Are More Likely To Be Recalled

A lot of finger pointing about recalled medical devices being more frequently a result of the accelerated approval process.

No duh.

See the Los Angeles Times Health Blog, Feb 15.

The FDA says the producers have been trying to get quick approval by claiming the new products are very similar to older, safe no big review or evaluation was needed.  The FDA gets beat up all the time for delaying approval of desperately needed treatment.

You can't have it both ways.   People want safe medicines and devices; this takes, on average, about ten years to accomplish (lab studies, animal studies, phase I, II, III trials, population studies)

On the other hand, people want advances in now.

So, under pressure, the companies AND the FDA try to thread the needle of getting more good stuff out quicker (for different motives).  Therefore, more problems surface.

Is this rocket science?

Or just politics?

Doc D

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