As stated by others CRL = Complete Response Letter. It essentially states we can not approve at the current time for the following reasons. It may or may not delineate requirements for overcoming the objections. Usually if a CRL is received the company will meet with the FDA to further define what is needed.
Note, the FDA can also flatly deny the FPDUA, but rarely does. It can also approve with qualifications, as well as approve without conditions.
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