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Cautionary Tales

Last week on LinkedIn, I shared a recently issued FDA Warning Letter that generated a lot of views and ‘likes.’ The topic of the regulatory citation in the Warning Letter was clinical trials records retention, always a point of interest. But it seems a lot of people, not just QA and regulatory types like me, like reading FDA Warning Letters, but why? The primary reason to read them is because they offer considerable information and insight into the real world application of c

Recently Published Guidance from the FDA

There have been a number of draft and final guidance documents published by the US Food and Drug Administration (FDA) in the past several weeks. Here are several relevant to clinical research. Draft Guidance Documents: Expansion of the Abbreviated 510(k) Program: Demonstrating Substantial Equivalence through Performance Criteria Guidance for Industry https://www.fda.gov/ucm/groups/fdagov-public/@fdagov-meddev-gen/documents/document/ucm604195.pdf In this draft guidance, the FD

Knock, Knock

I often emphasize that the FDA website has a wealth of publicly available information related to regulatory compliance, clinical research and development, ethics and human subjects’ protection, along with many other relevant topics. Today, I’d like to open the door to just one category of these valuable resources. The FDA wants to help people understand the regulatory requirements related to developing, evaluating, submitting and gaining approval for new medical devices, phar