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Jaded Past

10/01/20 3:17 PM

#950 RE: Boneride #949

EXACTLY!! And I found this bit of information on another forum...

The FDA will work with $ZSAN to get this fixed, it is minor amendment.


From FDA website: Minor Amendments
Minor amendments are those not classified as major, or are a response to a deficiency that could be adequately resolved through an information request (IR) or discipline review letter (DRL).

Minor amendments often consist of responses to deficiencies that are more easily addressed than those in a major amendment and typically require less extensive assessment by FDA.