Webinar

Office of Regulatory Operations

Office of Generic Drugs

June 30, 2015

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Office of Regulatory OperationsCommunications

Welcome

• Thank you for your interest in generic drugs and the ORO.

• This is the first webinar dedicated to ORO but we hope to continue holding these types of communications.

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Industry

Generic Drug Program

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Safe Effective

Quality

Interchangeable

Available

Today’s Discussion

• Division of Filing Review

• Division of Project Management

• Division of Labeling Review

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Division of Filing Review Communication Opportunities

Ted Palat, Pharm.D.

Supervisory Pharmacist (Acting)

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ANDAfiling@fda.hhs.gov

• Email contact for status requests on Abbreviated New Drug Applications (ANDAs) which are pending filing review and all pending Suitability Petitions.

• All status requests are actively researched prior to replying.

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DFRsupervisor@fda.hhs.gov

• Email contact to request a reconsideration of a refuse-to-receive (RTR) decision.

• Included in all RTR correspondences.

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Improved Applicant Notification

• DFR will notify all applicants by phone prior to sending an Information Request (IR) or Acceptable for Filing/RTR correspondence via email.

• These calls are only to provide notification and confirm contact information.

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Improved Applicant Notification

• If there is no answer, DFR will leave a message listing the ANDA number, the communication type, and the contact email to be used.

• The response clock, if any, starts the day after the email is sent to the contact email listed on the most recent form FDA 356h.

Division of Project Management(DPM)

CDR Dat Doan, PharmDActing Supervisory Project Manager

Division of Project Management

June 2015

Role of the RPM

• Manage the overall review process of ANDAs.• Act as the primary liaison/contact between FDA

and the applicant.• Committed to work with the various disciplines

and the applicant to complete the review process, meet GDUFA requirements, and facilitate approval of ANDAs.

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ANDA Review Process

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ANDA Review Process1.RPM assignments are random, not by drug class, except PEPFAR, PET, REMS.

2.OGD and OPQ are working towards AP/TA, often need IRs and ECDs, CRs are last resort.

• ECDs: Easily Correctable Deficiencies, sent by discipline PMs,10 days to respond

• IRs: Information Requests, sent by discipline PMs, 30 days to respond

• CRs: Complete Response Letters, sent by DPM/RPM, 1 yr to respond

3.Dunner Letters: if no response to CR letters for >1yr, OGD will request withdraw of ANDA.

• Please respond by providing reason for extension AND extension date

• Or request withdrawal of ANDA

4. Improve Communication13

Communication

• To improve understanding of wants and needs by all parties involved

• To improve outcome• To facilitate patient access

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RPM Communication to Industry*in addition to the communication with disciplines from IRs, ECDs

1. RPM introduction: ANDA assigned to RPM

2. TAD is set

3. No Go communication• Fatal Flaw, Major Deficiencies, TAD not on track, etc.

4. Pre-action communication

5. CR issuance

6. Post CR Meeting when requested/approved

7. Launch Planning (Status Update)

8. Go Communication: Action Letter expected

9. Approval/TA

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Communicating with OGD

• RPM is the primary contact, then TLs, then SPMs

• Please do not contact discipline PMs unless in response to an issued IR/ECD

• Only one representative from applicant should be contacting FDA about the ANDA

• Please follow timeline to call back, not daily

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Communication (cont’d)

Collaborative effort: • Help us help you• Need each other to succeed• High priority for OGD

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DPM Organization Charthttp://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDER/ucm119463.htm

*Updated periodically

DPM Staff – Intro(>40 RPMs hired since 10/1/2012)

1. RPMs• Catherine Poole• Dawn Kimble-Vance• Julie Kuriakose

2. TL role • LCDR Kevin Denny

3. SPM role• Dat Doan, Vince Sansone, David (Scott)

Vehovic

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DPM Staff Intro (cont’d)Julie Kuriakose, RPM

BACKGROUND

1.Joined OGD in May 2015

2.10+ years industry experienceo Started career in Quality Assurance at a large spice manufacturing plant monitoring

product quality and adherence to cGMP’so Continued on to a contract pharmaceutical manufacturing company working on:

• Drug product formulation development for solid oral dosage forms• Process development and scale-up• Clinical manufacturing of phase 1 - 3 clinical supplies• Process validation activities

o Continued career at a biotech firm working on:• Sterile drug product development and manufacturing for Phase 1 studies• Preparation of CMC sections for IND filing

WHY I JOINED THE FDA•To gain a better understanding of the laws that drive our industry and use my experience to strengthen FDA’s commitment to the public

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DPM Staff Intro (cont’d)Catherine Poole, RPM

Background

1. 12 years in industry

a) 510K submission

b) Team Leader in Quality Control Group

i. Assay Development/Optimization, Qualifications, Validations, Assay Transfers (internal and global) and Stability Programs.

ii. Contributed to several BLAs

iii. FDA Inspections, Internal/External Audits

iv. Phase 1 –> Approval/Post-Approval

2. Been with FDA almost 4 years

a) CBER – Vaccines/Blood Product BLAs

b) CDER/OGD – 1 year in August

3. Catherine.Poole@fda.hhs.gov

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DPM Staff Intro (cont’d)Dawn Kimble-Vance, RPM

BACKGROUND Joined OGD in October 2014 20+ years in industry leading all aspects of Global R&D: concept and formulation

development, project scale up, manufacturing and launch activities. Launched over 80 products globally, 10 new brands 3 US & international patents. Managed the development and launch process within OTC drugs: formulator then

moved to process scale up and manufacturing. 18+ years, managed multi-functional global teams (Latin America, Europe, Japan and

the US) Launched acceptable and compliant products with the FDA, EMA, Japan’s PMDA and

China FDA regulations. Involved in FDA audits of our manufacturing facilities and R&D centers.

WHY I WANTED TO WORK AT THE FDA To be part of the US Generic Regulatory Agency AND with industry understanding. To help the American public receive safe & effective medicines. To help the FDA deliver its mission.

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DPM Staff Intro (cont’d)LCDR Kevin Denny, RPM TL

Role as Team Leader

1.Organize drug review activities for a team of Regulatory Project Managers (RPM’s)

2.Perform quality checks on RPM projects

3.Develop operating procedures

4.Participate in strategic planning for the Division of Project Management (DPM)

5.Communicate and implement key developments to the RPMs

6.Plan workload distribution for the team

7.Provide a knowledge resource for team members

Background:

8.With FDA almost 2 years

9.Acting Team Leader – October 2014

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White Oak Campus, Building 75Silver Spring, MD 20993

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Division of Labeling ReviewECD communication

Katherine Won, PharmD, MBA

Division of Labeling Review (DLR)

Team Leader, Project Management

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ECD Issuance

• Labeling Project Manager (LPM) will check to see if the application’s last submission is older then 6 months

• If older then 6 months, LPM will reach out to the current POC listed in the 356h form to see if the information is current

• Applicant must respond within 10 days– There may be cases when the applicant is

requested to respond in less than 10 days

• FYI, DLR issues ~200 ECDs/month

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Preparing the ECD Amendment

• For application specific questions, contact the LPM listed in the ECD

• Do not respond to the ECD email directly as it is a “send-only” account

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After Amendment Receipt

• Applicant can choose to send a courtesy notification when an amendment has been submitted

• LPM will follow up if no response after 10 days

• General questions regarding labeling, contact the main number for DLR (240-402-8868)

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Questions?