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Posted On: 07/14/2020 5:12:43 PM
Post# of 154114
morokoy,
A CRL is completely different instance from RTF (refusal to file) letter which is what we got.
A CRL is a nightmare as is the FDA saying" Sorry, after studying your application we have decide we cannot issue a license.
A CRL is completely different instance from RTF (refusal to file) letter which is what we got.
A CRL is a nightmare as is the FDA saying" Sorry, after studying your application we have decide we cannot issue a license.
Quote:
For a pharmaceutical company, the unwanted package is a complete response letter (CRL) from the Food & Drug Administration laying out the reasons why a drug can't be approved. Covering safety, efficacy, and manufacturing, the CRL describes deficiencies, possible remedies, and options for moving ahead.
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