Drugs

FDA Helping Drug Makers on Continuous Manufacturing

CDER Emerging Technology Team chief Sau Lee says the agency is “taking proactive steps to facilitate the drug industry’s implementation of emerging technologies, including continuous manufacturing, to improve product quality and address many of the underlying causes of drug shortages and recalls.” Writing in an online position paper, Lee describes the differences between traditional batch manufacturing and continuous manufacturing and the benefits of the newer process.

While industries such as the chemical and petrochemical industries have already undergone a manufacturing evolution and use efficient continuous technologies to safely manufacture products, Lee writes, the transition to continuous manufacturing in the drug industry is still in its early stages for several reasons. He notes that start-up costs for such a transition can be high, although economic analyses have shown potential significant long-term savings. Also, he says, some technologies still need to mature before being commercially viable.

“For certain types of drugs, such as biological products,” Lee says, “the technology for producing them by continuous manufacturing may not exist. Research is underway to address these and other challenges. Furthermore, drug makers still perceive of regulatory uncertainty that may delay product approval when a new manufacturing technology is used.”

The agency is providing resources and information to help industry make the transition, he says. And it is training review staff and conducting internal research on risk areas associated with continuous manufacturing so it can better assess related technologies.

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FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

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FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome