Opioid, NME, And Generic Drugs Changes Plotted In US FDA's 2018 Policy Roadmap
‘Better informed patients,’ ‘drug competition,’ ‘biosimilar innovation’ – as well as nutrition and tobacco goals will be achieved through guidances, promotional plans and other items FDA will develop over the next year.
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US FDA explored whether existing law allowed for the higher standard, but determined new authority granted by Congress was necessary.
The Overdose Prevention Framework includes considering whether FDA should require new opioids show superior safety compared to existing products.
Commissioner Robert Califf said the new plan should be released in August and include prongs to continue fighting the ongoing prescription opioid epidemic, as well as confront a new synthetic fentanyl and methamphetamine problem.