(Total Views: 514)
Posted On: 07/11/2021 12:50:48 PM
Post# of 153937
Here is a GREAT way (for ALL of us) to know--print the letter. Odd huh?
https://pink.pharmaintelligence.informa.com/P...n-Triggers
couple of their conclusions:
#1--While refuse-to-file letters are relatively rare – only 4% of the new drug applications and efficacy supplements FDA received over the study period(2008-17) got such a letter
#2-- Only 5.4% of the applicant-disclosed reasons matched what FDA said in the letters themselves.
no big deal
https://pink.pharmaintelligence.informa.com/P...n-Triggers
couple of their conclusions:
#1--While refuse-to-file letters are relatively rare – only 4% of the new drug applications and efficacy supplements FDA received over the study period(2008-17) got such a letter
#2-- Only 5.4% of the applicant-disclosed reasons matched what FDA said in the letters themselves.
no big deal
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