how to interact and communicate with fda on quality...
TRANSCRIPT
How to Interact and Communicate with FDA on Quality Issues
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Tanya Clayton, MPH (Acting Division Director, Division I) CDR Bob Gaines, PharmD (Division Director, Division II)
Agenda
• CDER Reorganization • Office of Pharmaceutical Quality (OPQ) • Office of Program and Regulatory Operations
(OPRO) • Regulatory Business and Process Management
(RBPM) • Team-based Integrated Quality Assessment (IQA) • Communication
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Agenda (continued)
• Points to Consider • Contacts • Questions
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Office of Biotechnology
Products
Office of Testing and
Research
Office of Drug
Security, Integrity &
Recalls
Office of Unapproved Drugs and Labeling
Compliance
Office of Manufacturing and Product
Quality Office of Compliance
Office of Generic Drugs
Previous Current
Office of Pharmaceutical
Science
Office of New Drug
Quality Assessment
Office of Scientific
Investigations
Office of Surveillance
Office of Testing and
Research
Office of Policy for
Pharmaceutical Quality
Office of New Drug Products
Office of Process
and Facilities
Office of Program
and Regulatory Operations
Office of Biotechnology
Products Office of Lifecycle
Drug Products
Office of Unapproved Drugs and Labeling
Compliance
Office of Drug
Security, Integrity and
Response
Office of Scientific
Investigations
Office of Manufacturing
Quality
Office of Program
and Regulatory Operations
Office of Computational
Science
Office of Biostatistics
Office of Clinical
Pharmacology
Office of Study Integrity and Surveillance
Office of Bioequivalence
Office Research & Standards Office of
Regulatory Operations
Office of Generic Drug
Policy
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OPQ
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Mission
The Office of Pharmaceutical Quality assures that quality medicines are available to the American public
Vision The Office of Pharmaceutical Quality will be a global benchmark for regulation
of pharmaceutical quality
One Quality Voice
OPQ Objectives 1. Assure that all human drugs meet the same quality standards to
safeguard clinical performance;
2. Enhance science- and risk-based regulatory approaches;
3. Transform product quality oversight from a qualitative to a quantitative and expertise-based assessment;
– Product Quality Platform and Informatics – Quality Metrics – New Inspection Protocol Project
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OPQ Objectives (cont.) 4. Provide seamless integration of review, inspection, surveillance, policy, and
research across the product life cycle.
– Team-based Integrated Quality Assessment (IQA) – Lifecycle Management – Research and Surveillance Empowered by FDA internal laboratories
5. Encourage development and adoption of emerging pharmaceutical technology
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Office of Pharmaceutical Quality
Office of Program and Regulatory Operations
Acting Director: Giuseppe Randazzo
Immediate Office Acting Director: Janet Woodcock
Deputy Director: Lawrence Yu
Office of Policy for Pharm. Quality
Acting Director: Ashley Boam
Office of Lifecycle Drug Products
Acting Director: Susan Rosencrance
Office of Process and Facilities
Acting Director: Christine Moore
Office of New Drug Products
Acting Director: Sarah Pope Miksinski
Office of Surveillance
Acting Director: Russell Wesdyk
Office of Biotech. Products
Director: Steven Kozlowski
Office of Testing and Research
Director: Cindy Buhse
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OPRO Structure
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OPRO • Mission:
OPRO is a customer‐oriented, regulatory‐focused, and process‐centered organization that empowers OPQ with an operational framework fostering collaboration, efficiency, and quality.
• Vision: To be the model organization for regulatory and business operations across FDA centers.
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Regulatory Business Process Manager (RBPM)
• Centralized project managers for: • The Quality Assessment for all applications
submitted to CDER • Specialized projects
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RBPMs value to OPQ and Industry
• Centralized POC in OPQ for information regarding the quality portion of applications
• Provides a focal point for communication external to the review team
• Provides expert regulatory knowledge to the OPQ review team
• Facilitates teams to ensure the timely completion of work products
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RBPM value continued …
• Works with SMEs to identify and facilitate process improvement opportunities
• Streamlines communication with the sponsor
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Team-based Integrated Quality Assessment (IQA)
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Drug Product
Biopharm
Process
facility
Microbiology
Surveillance
Inspection
Drug Substance
Team-based Integrated Quality Assessment
BLA/NDA Original Process
Initial filing and risk
Assessment
Review Team
assignment
Inspection requested
Final Filing Review
and 74 day letter –
may include IRs
1st Cumulative
IR
Mid-cycle Review and
2nd Cumulative
IR
Inspection Finalized
Wrap up and Final Review
0 – 10d S: 0-14d P: 0-10d
S: 0-30d P:0-20d Within 60d
S: 5.25mo P: 3.25mo
S: 7mo P: 4mo
S: 8.0mo P: 5mo
Team Kick-off
Meeting
S: 0-45d P:0-30d
3rd Cumulative
IR
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Prior to MC As needed
In collaborating with Industry, OND and associated review offices, have experienced an increase in 1st cycle approvability rate from approximately 23% in 1992 to 73% in 2013/2014. This increase has been possible due to improved processes and the increased quality and completeness of original NDAs/BLAs submissions.
Filing Review (OGD)
IR #1
Response Received
and Reviewed
Complete Inspection
Wrap up and Final Review
0 – 60d 4mo – 6.5mo
Within 7.0mo
Within 9.0mo
Kick-Off Meeting
Within 90d
Assessment #1 and
Cumulative IR #1
Within 120d
IR #2
Response Received
and Reviewed
6.5mo – 8.5mo
Review Team
Assignment
Within 70d
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Current state: OPQ and OGD working to meet CY3/4 15 mth GDUFA date.
OPQ believes, in working with OGD and Industry, by CY5 the 1st cycle approvability rate for ANDAs can be improved. This goal is achievable provided the ANDA submissions we receive are of high quality and complete upon first submission.
Proposed example of CY 5 timeline:
Review cycle Communication
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Communication ANDA BLA/NDA Notes
74 day letter X Does not apply for ANDAs.
Mid-cycle communication X X ANDA: OPQ/OPRO RBPM sends comments directly to sponsor and notifies OGD/RPM.
BLA/NDA: OPQ/OPRO RBPM sends comments to OND RPM and sends to sponsor.
Wrap-up communication X X Not required, only as needed Information Request (IR) X X Process includes cumulative IR
letters; however, to prevent delays during review cycle additional IRs can be sent as needed.
Important points to consider • Contact the RBPM for all questions related to Quality-only
correspondences received (IR). • Continue to use the OGD/OND RPM as the point of contact
for general inquiries. • Be aware of your required information request response
deadline. • Only respond to IR with requested information. Additional
unsolicited information may impact review time and goal dates.
• Correctly code all submissions and amendments to ensure accurate triage and goal dates applied.
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Important points continued …
• Clearly identify all facility changes for all submissions
• Ensure all facilities and their responsibilities are clearly listed on the 356h
• Reach out to your assigned RBPM for any quality specific areas of uncertainty when submitting information
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OPRO Contacts • For all Quality related questions/communications, contact your assigned
OPQ/OPRO RBPM • For additional questions: Tanya Clayton: [email protected] Bob Gaines: [email protected]
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Questions?
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