GPhA: Possible Opioid Packaging Reqs Could Impose REMS-Like Market Barrier For Generics

The Generic Pharmaceutical Association is worried that an FDA proposal to deter opioid abuse could result in generic drugs being blocked from entering the market -- similar to what generic manufacturers say has been the effect of Risk Evaluation and Mitigation Strategies. New packaging technologies should not become a barrier to generic market entry and FDA should also avoid requiring use of a single type of technology, added GPhA, which is pushing the agency to establish a working group to...

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