A complete response letter (CRL) from the FDA delays a product’s entry to the market by an average of 14 months. Companies that receive the letters take an average of seven months just to respond to them.
CRL reasons can include:
-deficiencies in CMC requirements -deficiencies related to product labeling -comments related to specific clinical deficiencies
oh boy which way will it go ?
I bet you can’t guess which way I am rooting for hahahahahahaha
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