State Opioid Prescribing Databases Can Handle US FDA's Needs, Officials Say
Pharma firms might avoid paying for national opioid prescription monitoring database because state systems already talk to each other, although current operations still need some upgrades.
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President Trump's FY 2019 budget request includes $473m in new non-user fee revenue for the US agency, a reversal of the previous year's request.
Mandatory training could be reserved for physicians who want to prescribe opioids for longer-term use, as opposed to those who would prescribe recommended amounts in blister packs; evidence that blister packs would affect prescribing still is needed, however.
FDA seeks broader guidance than comments and information submitted at a January public hearing on standards testing and evaluations that could expand the variety of products approved as NRTs The docket is open to "recommend specific topics for direct, collective engagement and consideration by the" steering committee.