The FDA Process Validation training highlights opportunities in enhancing comprehension of constant process verification aligned with lifecycle concepts. It addresses early R&D phases through ...

This three-part series reviews how the Food and Drug Administration’s (FDA) January 2026 guidance, “General Wellness: Policy for Low Risk Devices”[1] (the General Wellness Guidance), affects companies ...

The US Food and Drug Administration (FDA) has issued draft guidance that spells out which types of drugs and medical devices are vulnerable to shortages and should be subject to risk management plan ...

On January 6, the US Food and Drug Administration (FDA) released two significant updates potentially important for companies operating in the consumer health technology space. The FDA’s revised ...

But as to the risk-based stratification, in the FDASIA Report FDA squarely promised Congress and the rest of the world that in concert with stakeholders the agency would develop a guidance document ...

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