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WHERE MEDICAL INNOVATIONS TAKE FLIGHT

APS researcher breaks down the challenges of ISO 10993 for E&L device testing

It’s commonplace in the CRO community: While researchers recognize the value of strict FDA rules set for biocompatibility testing, they’re continually frustrated by ISO stipulations that aren’t necessarily relevant when evaluating implantable medical devices. That means the researchers often spend unnecessary time and money on extractable and leachable (E&L) testing procedures that don’t result in […]

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preclinical

FDA’s plan to engage the public in the agency’s new effort to strengthen and modernize FDA’s regulatory framework

On 07 September, 2017, FDA announced its plan to engage the public in the agency’s new effort to strengthen and modernize FDA’s regulatory framework. FDA’s goal is to ensure that its policies and regulations keep pace with the challenges encountered in protecting consumers, and the opportunities to improve lives. This new effort includes areas where […]

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Strengthening EU-US cooperation in medicine inspections

New commitment allows FDA to share full inspection reports with European Commission and EMA The European Commission (EC), the United States (US) Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have signed a new confidentiality commitment that allows the US regulator to share non-public and commercially confidential information, including trade secret information […]

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