US FDA Needs ‘More Streamlined’ REMS Enforcement Authority, Inspector General Says
Additional power would allow the agency to punish 'simple' REMS violations and improve administration of risk management programs, according to a new report looking at FDA's oversight of opioids.
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Talks between US FDA and industry to extend the generic drug and prescription drug user fee programs may last into 2021.
As outside report urges increased planning and culture changes, FDA OTS Director Keller says recruitment will stop ‘order taking’ and move to ‘forecasting the hiring needs of each of the centers.’
US FDA says opioid and opioid use disorder treatment labels should suggest providers discuss naloxone availability with patients and caregivers and consider co-prescribing to patients at high-risk of overdose, but it does not mandate co-prescribing, the most aggressive (and costly) option that had been considered.