In accordance with 21 CFR 314.102(b):
FDA reviewers shall make every reasonable effort to communicate
promptly to applicants easily correctable deficiencies found in an
application or an abbreviated application when those deficiencies are
discovered, particularly deficiencies concerning chemistry,
manufacturing, and controls issues. The agency will also inform
applicants promptly through early communication such as Information
Requests (IRs) of the need for more data or information or for technical
changes in the application or the abbreviated application needed to
facilitate the agency’s review. This early communication is intended to
permit applicants to correct such readily identified deficiencies
relatively early in the review process and to submit an amendment
before the review period has elapsed. Such early communication would
not ordinarily apply to major scientific issues, which require
consideration of the entire pending application or abbreviated
application by agency managers as well as reviewing staff. Instead,
major scientific issues will ordinarily be addressed in a complete
response letter.
