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release of draft guidance for the pharmaceutical industry called, "Request for Quality Metrics." …describes a set of measurements to …evaluate the quality of the facilities and the processes that manufacturers use to make FDA-regulated drugs and biologics…encourages…manufacturers to conduct robust quality measurements on their own products..We look forward to receiving comments..

"Americans cannot afford to rely on 20th century methodologies for treatments when the world is on the cutting edge of new medical technologies. Federal agencies must be equipped to keep the U.S. at the forefront of medical innovation."… much of the report focuses on improving the FDA’s ability to work more quickly to evaluate and approve new devices and therapies.

And you thought the fight over prices of cancer and hepatitis drugs was hot….new cholesterol drugs is setting the stage for a battle over the high prices of those specialty medications and the possibility that millions of people will end up using them each year.