Will Continuous Manufacturing Mean Continuous Generic Delay? FDA Hears AAM's Warning
Association for Accessible Medicines calls for US FDA to guard against use of continuous manufacturing methods to protect brand drugs from batch-manufactured generic drugs that may be of lower but still acceptable quality. Then FDA approves first generic of a continuously manufactured drug.
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As the response to another wave of COVID-19 infections continues, fill rates of critical medicines such as methylprednisolone are dropping. But experts say the answer is not to concentrate manufacturing in US facilities, which could lead to further risks if US supply is disrupted.
Draft tracks ICH document, which touts the ‘efficiency, agility, and flexibility’ of continuous manufacturing while acknowledging the challenges around the developing practice, ‘particularly for products intended for commercialization internationally.’
A draft ICH guidance on continuous manufacturing has been opened up for comment by the FDA, as continuous manufacturing becomes an increasingly prominent topic for the generics industry.