A new guidance document issued by the FDA this week offers recommendations for how makers of prescription biosimilars and biologic reference products should approach promotional advertising and ...
FDA has published final guidance documents regarding validation and development of analytical procedures. On March 7, 2024, FDA published two final guidance documents regarding analytical procedures ...
The FDA's draft guidance focuses on optimizing radiopharmaceutical therapy dosages for oncology during clinical development, excluding initial dosages in first-in-human trials. Differences between ...
The Consumer Financial Protection Bureau (CFPB), which is undergoing significant changes under the Trump administration, has rescinded 67 guidance documents issued since 2011, including several that ...
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