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

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

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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