Fate of biosimilar drug industry tied to health bill
Hamster ovaries, mare's urine, pig intestines, blood. It's not a recipe for a witch's stew — they're all components of high-tech biologic drugs. Used to treat everything from cancer to arthritis, biologics are the fastest-growing class of medicines, with more than $40 billion in annual sales in the United States. But they're also expensive — many cost tens of thousands of dollars a year — and the FDA has no authority to approve lower-cost, generic versions. That will change if the health care bill is signed into law.
Good prediction: FDA targets counterfeit drugs
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FDA announces potential changes to medical device regulatory process
Controversy and uncertainty arise because new measures will likely increase the regulatory burden and delay clearances.
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