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US FDA Announces Updated Guidance Process

 
• By Sue Sutter

The agency also will not expand the guidance categories that may be issued “for immediate implementation” without prior public comment, but more guidance documents could be issued in Q&A or bulleted formats, the agency said.

Man with software "Updating..." screen
(Chanyanuch Wannasinlapin/Shutterstock)
Key Takeaways
  • In a final report on guidance best practices, the agency said it will lower the burden for the public to comment on draft guidances, but will not provide a detailed summary of comments or a line-by-line summary of changes made in the final version.

The US Food and Drug Administration is changing its guidance practices, but will not provide a detailed summary of public...

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