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Generic Drug Program Update PowerPoint Presentation

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Description : Download this report to get an introduction to generic drugs, gain Generic Drug Program Overview, Generic Drug User Fee Amendments (GDUFA), Drug Competition Action Plan (DCAP), FDA Office of Generic Drugs, etc.

Tags : Generic Drug, pharma, pharmaceutical, pharmaceutical industry, drugs, medicine, Generic Drugs, Generic Drug User Fee Amendments, GDUFA, Drug Competition Action Plan, DCAP, Pharmaceutical Research and Manufacturers of America

Published on : Jul 02, 2020 | Views : 2039 | Downloads : 0

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Slide 1-

1 Keynote: Generic Drug Program Update Sally Choe, PhD Director, Office of Generic Drugs, Center for Drug Evaluation and Research, U.S. Food and Drug Administration
Slide 2-

Outline 2 Introduction Generic Drug Program Overview Generic Drug User Fee Amendments (GDUFA) Drug Competition Action Plan (DCAP) Conclusion
Slide 3-

Introduction 3 FDA Office of Generic Drugs, CDER FDA Office of Study Integrity and Surveillance, Office of Translational Sciences (OTS), CDER PAREXEL Consulting FDA Office of Clinical Pharmacology, OTS, CDER Pfizer, Ann Arbor, MI BMS, Princeton, NJ University of Michigan, Ann Arbor, MI
Slide 4-

Generic Drug Program Overview
Slide 5-

Office of Generic Drugs (OGD) Director: Sally Choe, PhD Deputy Director: Howard Chazin, MD (Acting) Office of Research and Standards (ORS) Director: Rob Lionberger, PhD Deputy Director: Lei Zhang, PhD Division of Therapeutic Performance Division of Quantitative Methods & Modeling Office of Bioequivalence (OB) Director: Dale Conner, PharmD Acting Deputy Director: Ethan Stier, PhD Division of Bioequivalence I Division of Bioequivalence II Division of Bioequivalence III Division of Clinical Review Office of Generic Drug Policy (OGDP) Director: Maryll Toufanian, JD Deputy Director: Kristin Davis, JD Division of Legal and Regulatory Support Division of Policy Development Office of Regulatory Operations (ORO) Director: Edward (Ted) Sherwood Deputy Director: CDR Vincent Sansone, PharmD Division of Labeling Review 5 Division of Filing Review Division of Project Management Division of Quality Management Systems
Slide 6-

OGD Compliance ORP OPQ OND OSE OTS ORA OCC CDRH Others OMP OCOMM OSP OM U.S. FDA Generic Drug Program 6 Abbreviated new drug applications (ANDAs) involve multiple offices within FDA OGD issues regulatory action on ANDAs Office of Pharmaceutical Quality (OPQ) and OGD collaborate on technical review of ANDAs Many offices across CDER and FDA contribute to program success
Slide 7-

7 www.fda.gov Generic Drug Program
Slide 8-

Generic Drug User Fee Amendments (GDUFA)
Slide 9-

GDUFA 9 Reflects negotiated agreements with industry Goals based on assessment of program activities GDUFA I (2012) GDUFA II (2017) GDUFA II Commitment Letter www.fda.gov/GDUFA
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GDUFA II Features 10 Submission Review Performance Goals Original ANDA Review Program Enhancements Pre-ANDA Program and Subsequent Mid- Review-Cycle Meetings for Complex Products DMF Review Program Enhancements Facilities Enhanced Accountability and Reporting
Slide 11-

GDUFA Program Performance
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ANDA Receipts (Originals) 813 893 1103 968 1473 539 853 1306 1600 1400 1200 1000 800 600 400 200 0 FY10 FY11 FY12 FY13 FY14 FY15 FY16 FY17 Pre-GDUFA 12 GDUFA I GDUFA II 1044 FY18
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Predictability 13
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14
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Regulatory Actions 15 Under GDUFA, FDA has committed to take regulatory actions by the goal date: Approval (AP) Tentative Approval (TA) Complete Response Letter (CR or CRL)
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Filing - Refuse to Receive (RTR) (based on cohort year of submission) 30 25 20 15 10 5 0 19 25 13 8.3 FY 15 16 FY 16 FY 17 FY 18 % RTR
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Approval and Tentative Approval Totals 426 458 517 440 409 492 651 763 781 139 139 102 95 91 120 184 174 190 1200 1000 800 600 400 200 0 FY 10 FY 11 FY 12 FY 15 FY 16 FY 17 FY 18 FY 13 FY 14 AP TA GDUFA I 17 GDUFA II
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GUDFA Performance – Originals (new applications) 98 93 96 96 20 0 40 80 60 100 FY 15 FY 16 FY 17 FY 18 GDUFA 18 Goal 15 months 15 months 10 months 8-10 months
Slide 19-

Product-Specific Guidance (PSG) 19 PSGs provide detailed advice on the evidence recommended to demonstrate bioequivalence for a particular RLD They support the high first-cycle adequate rate for the bioequivalence sections of ANDAs The PSGs web page contains almost 1700 PSGs and new guidances are added every quarter
Slide 20-

Product-Specific Guidance 20
Slide 21-

Pre-ANDA Meetings for Complex Generics 21 Pre-ANDA meetings have new GDUFA II commitments and timelines Provide opportunities to discuss new or alternative bioequivalence approaches for complex products – Focus on content not covered by PSGs
Slide 22-

Pre-ANDA Meeting Requests 14 30 32 27 83 10 0 21 20 30 80 70 60 50 40 90 FY13 FY14 FY15 FY16 FY17 FY18 Number of Requests Received Fiscal Year 22
Slide 23-

Pre-ANDA Meeting Requests – Fiscal Year 2018 23
Slide 24-

GDUFA Science and Research 24 Provides the scientific foundation for recommendations on complex products Essential for pre-ANDA meetings and product-specific guidance development In 2018, GDUFA funded >$14M in OGD regulatory science research programs 24 new contracts and grants 75 ongoing research collaborations Visit www.fda.gov/gdufaregscience for more details
Slide 25-

Input into Research Priorities 25 The GDUFA Research program is focused on challenges to generic product development or assessment Stakeholder input was considered to develop the FY19 GDUFA Regulatory Science Priorities: Complex active ingredients, formulations, or dosage forms Complex routes of delivery Complex drug-device combinations Tools and methodologies for BE and substitutability evaluation Your input will determine FY20 priorities – 2019 Regulatory Science Initiatives Public Workshop will be held on Wednesday, May 1, 2019 on the White Oak Campus
Slide 26-

Additional Fiscal Year 2018 Program Highlights 26 Timely and successful update of Orange Book to reflect marketing status updates as required by FDARA Competitive generic therapy (CGT) designation and exclusivity requests Drug Competition Action Plan (DCAP)
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Drug Competition Action Plan (DCAP)
Slide 28-

DCAP Actions 28 Commissioner announced in June 2017 DCAP focuses on: Improving the efficiency of generic drug development, review, and approval processes Maximizing scientific and regulatory clarity with respect to generic drugs for complex products Closing loopholes that allow brand drug companies to “game” the system in ways that thwart generic competition
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Improving the Efficiency of Generic Drug Development, Review, and Approval 29 Good ANDA Submission Practices Draft Guidance Good ANDA Assessment Practices MAPP ANDA Submissions--Amendments to Abbreviated New Drug Applications Under GDUFA Final Guidance
Slide 30-

Maximizing Scientific and Regulatory Clarity for Complex Generic Drug Products 30 Issued 76 PSGs for complex generics in 2018 Published two guidances for industry: Assessing Adhesion with Transdermal and Topical Delivery Systems for ANDAs Revised Draft Guidance Assessing the Irritation and Sensitization Potential of Transdermal and Topical Delivery Systems for ANDAs Draft Guidance
Slide 31-

Closing Loopholes that Allow Brand Drug Companies to “Game” the System 31 In May 2018, FDA published a list of drug products about which FDA has received inquiries related to reference listed drug access In June 2018, FDA published two draft guidances: Development of a Shared System REMS Waivers of the Single, Shared System REMS Requirement In October 2018, FDA published revised draft guidance: Citizen Petitions and Petitions for Stay of Action Subject to Section 505(q) of the Federal Food, Drug, and Cosmetic Act
Slide 32-

Encouraging Development of Generic Drugs in Markets with Limited Competition 32 List of Off-Patent, Off-Exclusivity Drugs without an Approved Generic (Published in June 2017; updated biannually) Addition of patent submission dates to the Orange Book where available (Nov. 2017)
Slide 33-

Resources 33 Who to Contact for Questions Related to Generic Drugs Brief videos highlighting new features in GDUFA II on FDA.gov: GDUFA Overview Pre-ANDA Program for Complex Products Type II Drug Master Files (DMF) Update Performance Goals Goals Integration Review Status Updates Post Complete Response Letter (CRL) Meeting Requests for Reconsideration Review Classification
Slide 34-

Podcasts/Webinars 34
Slide 35-

Generic Drug Program 35 www.fda.gov
Slide 36-

Office of Generic Drugs Mission and Vision 36 Our Mission OGD makes high quality, affordable medicines available to the public. Our Vision OGD is the world leader in the science and regulation of generic medicines.
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