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FDA: P4 certifications must be accompanied by timely notice and verifiable delivery proof
Summary
FDA guidance states that when an applicant files a Paragraph IV certification for a later-listed patent or use code, the applicant must simultaneously send notice and provide adequate, verifiable documentation of both sending and receipt; generic proof-of-delivery forms that omit recipient identity often fail.
Heather Strandberg of FDA's Office of Generic Drug Policy reminded ANDA applicants that submitting a Paragraph IV certification triggers strict notice and documentation obligations. "If an applicant elects to submit a P4 certification to a timely filed later listed patent or use code, the applicant must also comply with the notice requirements under 21 CFR 314.95," she said, and noted that prior notice sent for an earlier P4 certification is not sufficient for a newly listed use code.
Strandberg outlined acceptable proof: a registered-mail receipt, certified-mail receipt, or a designated delivery-service receipt showing delivery date, delivery location, and the name or identity of the person who signed for the package. She warned that receipts stating "signature release on file" or indicating that "a signature was not required" are common deficiencies and do not meet the regulation's signature-proof requirement.
