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Beyond the Trifecta: Best Practices for a Successful Promotional Review Committee (PRC) Process
April 30, 2024
To reduce frustration within a promotional review committee (PRC), the PRC must be a well-oiled machine firing on all cylinders and working at optimum capacity. How does a PRC achieve this? By developing and implementing best practices. Rock star reviewers are great but having them on your team can...
Cleaning Validation and GMP reviews of those protocols are challenging. They become even more challenging at a Contract Manufacturing Organization (CMO) where compliance assessments to in-house...
FDA recently updated its informed consent guidance in the form of an Information Sheet. The new document reflects the Agency’s current thinking on the informed consent process utilized in...
FDA Revisits the Topic of INDs for Dietary Supplements
One of the fundamental disconnects in the dietary supplement world is that despite the fact that manufacturers of dietary supplements are not allowed to make claims regarding effects on diseases,...
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