US FDA Pushing For Generic Alternatives To Long-Acting Injectables, Implants
Complexity of manufacturing process for long-acting polymer-based injectable drugs, implants and in situ forming gels is delaying development of generic alternatives, but the US FDA hopes that new research into the formulation of these drugs will shed some light on how manufacturing processes can be replicated.
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Former deputy commissioner will also likely push increased use of biomarkers and more flexibility in off-label communication, among other reforms.
FDA will be able to give scientific advice and sponsors can familiarize reviewers with upcoming generic applications for complex products under new provision in GDUFA II.
Site-based metrics praised; lot acceptance rates, invalidated OOS rates discouraged. Agency official admits some proposed metrics were “not the best.”