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The US Food and Drug Administration (FDA) this week issued a sweeping draft guidance intended to help stakeholders incorporate patient experience data through the use of meaningful clinical outcome assessments (COAs).

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Racial, ethnic and sociodemographic disparities that are present in clinical trials and compassionate use agreements for cancer immunotherapy during the pre-approval period are reduced, but not eliminated after the US Food and Drug Administration ...

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MHRA proposed a slate of medtech reforms considering the Cumberlege Review and the opportunity presented by Brexit. The proposals were intended to improve patient safety, increase transparency, more closely align the UK with international practice...

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Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.

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A global regulatory group is seeking industry participants for two pilot programs exploring a common regulatory framework for assessing manufacturing facilities in hybrid inspections and for reviewing postapproval changes.  

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Both industry and clinicians asked the US Food and Drug Administration (FDA) for clarification related to the evaluation of cellular starting materials in its draft guidance on chimeric antigen receptor (CAR) T cell product development.

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Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.

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The former top US Food and Drug Administration (FDA) cybersecurity expert says it’s only a matter of time before disaster strikes in the form of a medical device exploit that could harm patients. To get ahead of the problem, he said the agency nee...

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A panel of experts recommended the inclusion of an Omicron component in future COVID-19 vaccine boosters in the United States. Public health officials suspect another surge in COVID-19 cases this fall and are considering boosters with an updated s...

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Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.

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The US Food and Drug Administration (FDA) has issued a new proposed rule that would allow drug companies to add conditions for consumers to access nonprescription drug products.

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Australia’s Therapeutic Goods Administration (TGA) has updated its clinical evidence guidelines for medical devices, adding new chapters on software as a medical device (SaMD) and personalized medical devices (PMDs), prompted by regulatory framewo...

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