Today, FDA/CDRH issued a Guidance on Appeals Processes. To read a story, go
here.
We,
Regulatory Doctor, wrote an article on the same topic last year, entitled "Demystifying the FDA Appeals Process," published by RAPS. To read more, go
here.
If you have read or are willing to read both articles, would you please be willing to share your comments (e.g., any gaps, issues to be better addressed, etc.)?
Your comments will help us connect the dots better and closer.
Thank you very much for your willingness, time, efforts and consideration in advance.