office of pharmaceutical quality office of program … is opro? •office of program and regulatory...
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Office of Program and Regulatory Operations
FDA/CDER’s Office of Pharmaceutical Quality
November 2, 2015
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Proposed Organizational Structure -
Office of Pharmaceutical Quality OFFICE OF
PHARMACEUTICAL QUALITY
OFFICE OF BIOTECHNOLOGY
PRODUCTS
DIVISION OF BIOTECHNOLOGY
REVIEW AND RESEARCH I
DIVISION OF BIOTECHNOLOGY
REVIEW AND RESEARCH II
DIVISION OF BIOTECHNOLOGY
REVIEW AND RESEARCH III
DIVISION OF BIOTECHNOLOGY
REVIEW AND RESEARCH IV
OFFICE OF NEW DRUG PRODUCTS
DIVISION OF NEW DRUG API
DIVISION OF NEW DRUG PRODUCTS I
DIVISION OF NEW DRUG PRODUCTS II
DIVISION OF LIFECYCLE API
DIVISION OF BIOPHARMACEUTI
CS
OFFICE OF POLICY
DIVISION OF REGULATIONS, GUIDANCE AND
STANDARDS
DIVISION OF INTERNAL
POLICIES AND PROGRAMS
OFFICE OF PROCESS AND
FACILITIES
DIVISION OF DRUG PRODUCT PROCESS I
DIVISION OF DRUG PRODUCT
PROCESS II
DIVISION OF DRUG PRODUCT
PROCESS III
DIVISION OF MICROBIOLOGY
DIVISION OF INSPECTIONAL ASSESSMENT
OFFICE OF SURVEILLANCE
DIVISION OF QUALITY
INTELLIGENCE, RISK ANALYSIS AND MODELING
DIVISION OF QUALITY
SURVEILLANCE ASSESSMENT
OFFICE OF TESTING AND
RESEARCH
DIVISION OF PRODUCT QUALITY
RESEARCH
DIVISION OF PHARMACEUTICAL
ANALYSIS
OFFICE OF PROGRAM AND REGULATORY
OPERATIONS
DIVISION OF REGULATORY &
BUSINESS PROCESS
MANAGEMENT I
DIVISION OF REGULATORY &
BUSINESS PROCESS
MANAGEMENT II
DIVISION OF ORGANIZATIONAL
EXCELLENCE, LEARNING AND PROFESSIONAL DEVELOPMENT
OFFICE OF LIFECYCLE DRUG PRODUCTS
DIVISION OF IMMEDIATE RELEASE
PRODUCTS I
DIVISION OF IMMEDIATE RELEASE
PRODUCTS II
DIVISION OF
MODIFIED RELEASE
PRODUCTS
DIVISION OF LIQUID-BASED
PRODUCTS
DIVISION OF POST-MARKETING ACTIVITIES I
DIVISION OF POST-MARKETING ACTIVITIES II
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What is OPRO?
• Office of Program and Regulatory Operations
(OPRO)
• OPRO will be responsible for working with
subject matter experts across the OPQ matrix
organization to:
1.Co-lead and facilitate marketing applications,
2.Develop, design, implement, and continuously
improve an internal quality management system,
3.Facilitate learning and professional development of all
staff.
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OPRO’s Mission and Vision
• 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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Trivia!
• If you have a facility that you are no longer using and is no longer
applicable to your ANDA, what do you do?
a. Do nothing and wait until fees are billed
b. Submit an updated 356H and withdrawal notification cover
letter highlighting the facility change via the electronic gateway
c. Send in a new 356H without acknowledging the changes in
facilities
d. Wait until you receive an inspection notification
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Overview of OPRO – Core Values
“OPRO is a customer service based organization that…
• … Develops people by optimizing personal and professional
achievement through collaboration and assessment.”
• … Provides effective leadership by facilitating cross‐disciplinary
teams for OPQ work products (e.g., review, procedure, and
training).”
• … Operates proactively by anticipating internal and external
customer needs.”
• … Collaborates with internal and external partners to design and
implement processes to ensure:
– Accountability, Continuous improvement, Sustainability (knowledge
management), Consistency of work products, Predictability”
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OPRO Organizational Structure
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Trivia!
If you have an inquiry about your application’s overall status or TAD,
who do you contact?
a. Lawrence Yu
b. Kathleen “Cook” Uhl
c. OPQ RBPM
d. OGD RPM
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Trivia!
How do you submit a request for a Facility Withdrawal from an
ANDA/sANDA?
a. Call the RBPM
b. Submit a CBE-0 sANDA
c. Submit a Correspondence titled Withdrawal Request (Either
Original/Facility OR Supplement/Facility)
d. Submit a CBE-30 sANDA
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Tanya Clayton, MS Division Director (Acting)
Division of Regulatory and Business Process
Management I
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Division I – Branch II
ANDA Originals
Modified-Release and Liquids • Craig Kiester (Acting
Branch Chief)
• Candice Cottle-
Delisle
• Tania Mazza
• Steven Yang
• Eileen Monaghan
• Ankara “Nikki” Yokum
• Katelyn Overstreet
• Jaimie Jones
• Filita Moore
• Mark Gonitzke
• Christina Pleas
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CDR Craig Kiester, RPh, MS, RAC
Branch Chief (Acting)
Division I/Branch II
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Tania Mazza, PharmD
Division I – Branch II
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LCDR Steven Yang, PharmD
Division I – Branch II
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Ankara “Nikki” Yokum, PharmD
Division I – Branch II
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Filita O. Moore, MBA, BSN, RN, NE-BC
Division I – Branch II
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Candice Cottle-Delisle, MS, BSN, RN
Division I – Branch II
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Jaimie Jones, PharmD
Division I – Branch II
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Trivia!
If you receive your IR from the RBPM and you realize that you aren’t
able to respond in the requested time, what do you do?
a. Do nothing and respond whenever it is convenient
b. Notify the OPRO Division Director
c. Notify the OPRO RBPM within 7 days of receipt
d. Notify the OGD RPM no later than 30 days after receiving the
IR
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Trivia!
On the 356h form which facilities should be included?
a. All Drug Product Manufacturing Sites
b. All Drug Substance Manufacturing Sites
c. All testing sites used by the DP or DS Manufacturer
d. All the above
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CDR Robert Gaines, PharmD Division Director
Division of Regulatory and Business Process
Management II
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Division II – Branch III
ANDA Originals
Immediate-Release • Hany Edward (Acting
Branch Chief)
• Simon Eng
• Nima Ossareh
• Maya Johnson-Nimo
• Trellis Adams
• Brijet Burton
• Jonee Mearns
• Jennifer Nguyen
• Helina Zenebe
• Leigh Ann Sears
• Savan Khanna
• Nuri Tawwab
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Hany S Edward, PharmD, MS
Branch Chief (Acting)
Division II – Branch III
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CAPT Simon Eng, PharmD
Division II – Branch III
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CAPT Trellis Adams, MSHS, BSN,
WCC, CPHM
Division II – Branch III
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Jennifer Nguyen, PharmD
Division II – Branch III
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Maya J. Johnson-Nimo
Division II – Branch III
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Leigh Ann Sears, MAHS, BSN
Division II – Branch III
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Savan Khanna, PharmD
Division II – Branch III
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Nima Ossareh, PharmD
Division II – Branch III
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CDR Jonee Mearns
Division II – Branch III
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LT Nuri Tawwab, PharmD
Division II – Branch III
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Trivia!
• If the Agency denies your ANDA CBE0/30 supplement and request
that it be considered a PAS, you should subsequently submit a
withdraw request for the CBE0/30 supplement.
a. True
b. False
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Trivia!
When submitting a CBE-30 application which is the best day to follow-
up with the Grant/Deny Status?
a. Day 7
b. Day 14
c. Day 0
d. Day 29
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Division II – Branch IV
ANDA Supplements
• Benjamin Danso
(Acting Branch Chief)
• Olugbenga
Okubadejo
• Reynolds Cantave
• Chinedu Ebonine
• Kimberly Hudgens
• Hongly La
• Luz E. Rivera
• Jackie Truffer
• Yajun “Jason” Tu
• Ryan Zettle
• Avani Patel
• Grecia Edwards
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LCDR, Benjamin Danso, PharmD
Branch Chief (Acting)
Division II – Branch IV
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Olugbenga Okubadejo, PharmD
Division II – Branch IV
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Hongly La, PharmD
Division II – Branch IV
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Kimberly Hudgens, MSHCA, MBA
Division II – Branch IV
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LCDR Ryan Zettle, PharmD
Division II – Branch IV
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LCDR Luz E Rivera, PsyD
Division II – Branch IV
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Yajun “Jason” Tu, PharmD, PhD
Division II – Branch IV
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Chinedu Ebonine, PharmD
Division II – Branch IV
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Rey Cantave, BS, PharmD
Division II – Branch IV
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Grecia Edwards, PharmD
Division II – Branch IV
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Avani Patel, PharmD
Division II – Branch IV
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Lloyd Ballou Division Director (Acting)
Division of Organizational Excellence, Training and
Development
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Division III – Branch V
Learning and Professional
Development
• Lisa Matthews (Acting Branch Chief)
• Pamela Grant
• Nicholas Humbert
• Tandra Latham
• Rebecca McKnight
• Cecily Nelson
• Kristin Phucas
• Janet Wilson 49
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Division III – Branch V
Lisa Matthews, PhD
Branch Chief (Acting)
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Division III – Branch VI
Organizational Excellence
• Jorge Rondon (Acting Branch Chief)
• Lionel Edlam
• Tina Ennis
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Division III – Branch VI
Jorge Rondon, PMP, LSSMBB
Branch Chief (Acting)
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What are the Functional
Areas in OPRO?
• OE - Organizational Excellence
• LPD– Learning and Professional
Development
• RBPM – Regulatory Business Process
Management
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Regulatory Business Process Manager
(RBPM)
• Centralized project managers for:
• The Quality Assessment for all application
types and
• Specialized projects
• Work across all sub-offices in OPQ to
provide project management and
leadership
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What value does the RBPM offer OPQ?
• Centralized POC in OPQ for information
regarding the quality portion of ANDAs
• 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
• Works with subject matter experts to identify and
facilitate process improvement opportunities
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Trivia!
If you submit an amendment and have no changes in your facilities
from the previous amendment, you should do the following on your
356h:
a. Type “See previous submission-no changes” and therefore do
not list any facilities
b. Only list your drug substance and drug product manufactures,
leaving out any testing facilities
c. Fill out the 356h in its entirety, listing all relevant facilities, even
if they are the same as the last time
d. None of the above.
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Trivia!
When submitting a 356h form for a new submission (Original or PAS) if
Facility “X” is a new site and indicated on the form as “New”, does the
356h form need to be continuously indicated as New on subsequent
amendments prior to the approval of the application?
a. Yes
b. No
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