Acetaminophen May Get Pulled From Rx Combo Products After Narrow Vote
FDA will have to balance the goal of preventing liver injury with concerns about access to treatment and narcotic abuse as it weighs whether to implement a joint advisory committee's narrow recommendation to remove acetaminophen from combination Rx products
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The Anesthetics and Life Support Drugs Advisory Committee discussed analgesics at 11 of 14 meetings during the past four years, anesthetics at three, and life support drugs at none.
FDA Restrictions On Rx Acetaminophen Show How Practical Concerns Influence Safety Actions
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.
CDER Ombudsman Referees Increasing Number Of Internal Scientific Disputes
Last year, Virginia Behr, the ombudsman for FDA's Center for Drug Evaluation and Research, dealt with the usual consumer and industry complaints about off-label drug promotion, marketing of unapproved drugs and unethical research conduct. But she also played a greater role mediating scientific disputes between FDA staff