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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CDER-based program lead by Marta Sokolowska will also handle benzodiazepine and stimulants activities and consult on relevant application assessments.
US FDA commissioner nominee could face a slew of questions about non-drug issues such as e-cigarette regulation, which may mean pharma must read between the lines for insight into his drug-related policy stances.
Trials will be mandated as part of new authority granted by SUPPORT Act and are intended to determine whether opioid efficacy decreases with long-term use.