How to Interact and Communicate with FDA on
Quality Issues
1
Tanya Clayton, MPH (Acting Division Director, Division I)
CDR Bob Gaines, PharmD (Division Director, Division II)
Agenda
• CDER Reorganization
• Organizational Structure (OPQ and OPRO)
• Office of Program and Regulatory Operations (OPRO)
• Regulatory Business and Process Management (RBPM)
• Team-based Integrated Quality Assessment (IQA)
• Communication
• Points to Consider
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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
QualityOffice of
Compliance
Office of
Generic Drugs
PreviousCurrent
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
& StandardsOffice 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 Objectives1. 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 OperationsActing Director:
Giuseppe Randazzo
Immediate OfficeActing Director: Janet Woodcock
Deputy Director: Lawrence Yu
Office of Policy for
Pharm. QualityActing Director:
Ashley Boam
Office of Lifecycle
Drug ProductsActing Director:
Susan Rosencrance
Office of Process and
FacilitiesActing Director:
Christine Moore
Office of New Drug
ProductsActing Director:
Sarah Pope Miksinski
Office of Surveillance
Acting Director:
Russell Wesdyk
Office of Biotech.
ProductsDirector:
Steven Kozlowski
Office of Testing and
ResearchDirector:
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 0
• Works with subject matter experts (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 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 – 10dS: 0-14d
P: 0-10d
S: 0-30d
P:0-20dWithin 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
CompleteInspection
RBPM finalizes
IQA/sends to OGD
0 – 60d4mo –
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 Final Review
completed
6.5mo –
8.5mo
Review Team
Assignment
Within 70d
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Current state: OPQ and OGD working to meet
Cohort Year (CY) 3/4 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 10 mth CY 5 timeline:
ANDA Original Process
Review cycle Communication
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Communication ANDA BLA/NDA Notes
74 day letter X Does not apply for ANDAs.
Cumulative IR #1 (ANDA);
Mid-cycle communication
(NDA – program products)
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 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 0
• 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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