加强沟通透明度试点-Vehovic.pdf

1、Transparency Pilot for Enhanced CommunicationsScott Vehovic,MBA,R.Ph.Commander,US Public Health ServiceDivision of Project Management(DPM),Office of Generic Drugs(OGD)CDER|US FDAGeneric Drugs Forum April 9,2025fda.gov/cdersbiafda.gov/cdersbia2Learning Objectives Recognize historical background of st

2、atus updates for Abbreviated New Drug Applications(ANDA)within OGD Provide overview of OGDs transparency pilot and enhanced communications Describe benefits of pilot and increased transparency Outline helpful hints beneficial to the communications process between applicants and Regulatory Project Ma

3、nagers(RPM)fda.gov/cdersbiafda.gov/cdersbia3History of ANDA status communicationsfda.gov/cdersbiafda.gov/cdersbia4History of ANDA status updates Occurred during open review cycle Emails and phone calls often applicant initiated Use of common phrases to describe discipline review status Missed goal d

4、ates and complex regulatory issuesfda.gov/cdersbiafda.gov/cdersbia5History of ANDA status updates Timing is known/predictable Provided an estimated completion date Timing is unknown/not predictable Provided an estimated timing for additional update Short term vs.long termfda.gov/cdersbiafda.gov/cder

5、sbia6Steps to Increase Communication Transparency Per the GDUFA III Commitment Letter,section II.B.6.c:“If an RPM learns that FDA is likely to miss the goal date for an ANDA,the RPM will notify the applicant of the delay in taking an action,identify the general reason for the delay including the out

6、standing discipline(s),if any,and the estimated time for FDAs action on the application.”fda.gov/cdersbiafda.gov/cdersbia7Steps to Increase Communication Transparency Applicant centric process Increased frequency,teleconferences,and management/leadership participation Enhanced language,where applica