造成重大后果的“轻微”监管错误-Phan.pdf

1、Minor Regulatory Errors with Major ConsequencesThu Suzanne Phan,PharmDPharmacist,Patent and Exclusivity TeamDivision of Legal and Regulatory Support(DLRS),Office of Generic Drug Policy(OGDP),Office of Generic Drugs(OGD)CDER|US FDASBIA Generic Drug Forum 2025 April 9-10,2025fda.gov/cdersbiafda.gov/cd

2、ersbia2Learning ObjectivesReview the requirements for proper documentation of notice of PIV certification under 21 CFR 314.95Review patent certification requirements under 21 CFR 314.94(a)(12)(vi)Other Reminders Docket Numbers 356h Formsfda.gov/cdersbiafda.gov/cdersbia3Notice documents missing,not p

3、rovided to FDANotice documents dont align or are incomplete was notice appropriately provided?Notifying FDA if litigation is or is not filed within the 45-day period after receipt of notice Common Issuesfda.gov/cdersbiafda.gov/cdersbia4Notification of PIV Certification-Original SubmissionSection 505

4、(j)(2)(B);21 CFR 314.95Applicant must send notice of Paragraph IV certification to each owner of the patent that is the subject of the PIV certification and the NDA holder within 20 days after the date of the postmark on the PIV acknowledgment letter Applicant must submit documentation of timely sen

5、ding and receipt of noticefda.gov/cdersbiafda.gov/cdersbia5Applicants that file a paragraph IV patent certification must subsequently amend their ANDA to provide documentation to FDA regarding(1)their notice of certification that was received by the patent owner(s)and NDA holder and(2)any legal acti

6、on that has been taken against the applicant under that paragraph IV notice.Specifically,applicants must amend their ANDA to provide documentation:That their notice of a paragraph IV certification was sent on a date that complies with the time frame provided in the regulations for sending this notic