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How to avoid declines: dates, letterhead, Orange Book references and portal tips
Summary
The presenter warned that common reasons for declines include incorrect dating (must be within 7 days of FDA receive date), missing company letterhead or contact information, and failing to reference the Orange Book or an approved suitability petition.
The presenter listed routine submission errors that lead to declines and gave explicit formatting rules: “The date of your document should be within 7 days of the FDA receive date.” She added that submissions should include company letterhead and complete contact information so the agency can communicate with applicants.
She emphasized that the submission must reference the product name as listed in the Orange Book or be related to an approved suitability petition; otherwise, the correspondence may be declined for not referring to an approved strength. Attendees were told to include related ANDA numbers in both portal fields and uploaded documents when applicable and to avoid uploading multiple copies or unrelated controls.
