FDA’s Rx Acetaminophen Safety Program Ramps Up Enforcement
This article was originally published in The Pink Sheet Daily
Some manufacturers have not met a deadline FDA set three years ago to limit the amount of acetaminophen in prescription combination products to no more than 325 mg.
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Because the agency can move faster on Rx products than OTCs, non-prescription products will have higher acetaminophen levels than Rx drugs, at least for the time being.
NCI networks had vast under accrual in the past year, but Sharpless says industry has been affected to a greater degree. He says the institute also has been better at accruing minority patients.
FDA’s 2019 survey of 2,000 providers finds 31% do not know what biosimilars are and 30% of primary care physicians do not know what an accelerated approval drug is. Another survey of low- or non-internet users finds a toll-free number is the best way for them to find information about a drug’s risks.