procedure questions and safety

By the Regenerative Evidence Guide Team Expanded access and clinical trial participation are two different FDA pathways to an unapproved product, and confusing them is an easy, costly mistake. A …

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By the Regenerative Evidence Guide Team What Does "FDA Registered" Mean? "FDA registered" means a facility has told the FDA where it operates and what it makes there. It does not mean the FDA …

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By the Regenerative Evidence Guide Team Research Participant Payments: What to Know Before You Sign a Consent Form Research participant payments are a normal part of many studies, but federal rules …

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By the Regenerative Evidence Guide Team What Does "Investigational New Drug (IND)" Status Actually Mean? An Investigational New Drug (IND) application is a Food and Drug Administration (FDA) filing …

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By the Regenerative Evidence Guide Team What an Institutional Review Board does, in plain terms An Institutional Review Board (IRB) is a federally required committee that reviews human-subjects …

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By the Regenerative Evidence Guide Team An adverse event report is a description of a health problem someone experienced after using a medical product, filed with a regulator like the FDA. A single …

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