ANDA 错过目标日期-Sherwood.pdf

1、ANDA Missed Goal DatesEdward SherwoodOffice of Regulatory OperationsOffice of Generic DrugsCenter for Drug Evaluation and ResearchApril 9,2025fda.gov/cdersbia2Learning Objectives Describe a missed goal date What happens with a miss Causes of missed goal dates Public informationfda.gov/cdersbia3 FDA

2、hears frustration with misses FDA apologizes for misses FDA does not like misses FDA never gives up on an ANDABackgroundfda.gov/cdersbia4 Completion and communication dateAll discipline assessmentsAll facility evaluations(includes inspections and equivalents)Letter issued What is a Goal Date?fda.gov

3、/cdersbia5 Assessors&PMs want approvals Approvals often easier for assessors FDA wants high approval counts FDA desires approvals on the earliest lawful approval date(ELAD)FDA mandates appropriate approvals Goal Dates Not Approval Datesfda.gov/cdersbia6 FDA did not complete and communicate by the cu

4、rrent goal dateMay include extensions(noted in Acknowledgement Letters)May be the longer of two goal dates from Acknowledgement LetterWhat is a Goal Date Missfda.gov/cdersbia7Acknowledgement Letter“the GDUFA goal date for review of this priority major amendment is June 20,2024.If FDA determines that

5、 an inspection is required to validate the information contained in this priority major amendment and a Pre-Submission Facility Correspondence was not submitted or not accepted,the GDUFA goal date for review of this priority major amendment is October 20,2024.”fda.gov/cdersbia8Acknowledgement Letter

6、(cont.)“.the GDUFA goal dateis June 20,2024.If FDA determines that an inspection is requiredthe GDUFA goal date for review of this priority major amendment is October 20,2024.”Oct.1 AP(with inspection/equivalent)is a make!Oct.31 CRL is a miss Oct.31 AP is a make!(Imminent Action)AP=Approval CRL=Comp