FDA has changed its sterility testing requirements for biological products, allowing for greater flexibility and continued improvement. Gareth MacDonald shared in a recent article in in-Pharma that with advanced technologies, patients and biologics producers benefit from these changes by “yielding accurate and reliable results in less time and with less operator intervention,” allowing for a reduced risk of human error through contamination. Although these requirements don’t give absolute assurance for a safe product, FDA suggests that the testing is “sufficient” and has several benefits. To read more about this topic, click here. And to review the new FDA ruling, go to the FDA website here.
Obstacles Facing Biosimilars
Still in its infancy in the U.S., the industry faces some growing pains.
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