Since its inception, the Generic Drug User Fee Amendments (GDUFA) has offered the promise of reducing the backlog of new generic drug applications and stepping up inspections of all plants to ensure parity and consistent high quality manufacturing for every drug product sold in the United States. This new Food and Drug Administration (FDA) law tightens the focus on the production of raw materials and the manufacturing of finished drugs available for sale in the US to ensure the delivery of safe, effective medicines to Americans and good progress has been made. On the flip side, however, we have also seen the fall-out of a law that can harm small-to-medium US manufacturers, leading to less innovation and overall competition in the industry.
Don’t get me wrong: holding all manufacturers to the same high standard in generic drug manufacturing should be table-stakes in today’s world, and it is a shame this was not the reality from the get-go. Due to cultural differences and a physical distance it has been difficult to hold manufacturers in Asia to the same standards as in the US.
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