In March 2026, the Food and Drug Administration (FDA) issued draft guidance for the industry, New Clinical Investigation Exclusivity ...
In early March 2026, the U.S. Food and Drug Administration (FDA) issued updates to its Q&A guidance interpreting and implementing the Biologics ...
The Food and Drug Administration is scrutinizing the common practice of giving coronavirus and flu shots together, signaling a reversal of years of federal guidance and a broader crackdown on ...
The FDA’s recent announcement to reduce, and in some cases replace, animal testing for monoclonal antibodies and other therapeutics represents one of the most consequential regulatory developments in ...
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