Arthur Fabian, PhD February 7, 2007 FDA Public Meeting Rockville MD.

Slides:

Advertisements

Similar presentations

AXINN, VELTROP & HARKRIDER LLP © 2007 | AXINN, VELTROP & HARKRIDER LLP Click To Modify Title Name Goes Here FDA Hearings on the BPCI Act.

Advertisements

Anticounterfeiting of Solid Oral Dosage Forms Hemant N. Joshi, Ph.D., MBA Tara Innovations LLC Parsippany, NJ

VALIDATION What is the new guidance?. What is a Compliance Policy Guide? Explain FDA policy on regulatory issues CGMP regulations and application commitments.

Batch Reworking and Reprocessing

Integrating CMC Review & Inspection Industry Recommendations Joe Anisko April 24, 2003.

APIs – global business developments Gian Mario Baccalini EFCG Board Member, Chairman of EFCG Pharma Business Committee President, B&P Development Srl,

Sultan Ghani WHO Prequalification Programme of Priority Essential Medicines, October 2010, Abu Dhabi, U.A.E. Active Pharmaceutical Ingredient Master.

United Nations Statistics Division ISIC Rev.4 Application rules.

Christine Simmon Senior Vice President, Policy & Strategic Alliances Generic Pharmaceutical Association November 6, 2014 Biologics Naming.

+ Drug Development and Review Process. + Objectives Learn the processes involved in drug discovery and development Define the phases involved in FDA drug.

Variations to Prequalified Medicines Rutendo Kuwana Workshop on WHO prequalification requirements for reproductive health medicines, Jakarta, October 2009.

Manufacturing Subcommittee of the Advisory Committee for Pharmaceutical Science July 20-21, 2004 Ajaz S. Hussain, Ph.D. Deputy Director Office of Pharmaceutical.

COMPARABILITY PROTOCOLS ACPS March 12-13, 2003 Stephen K. Moore, Ph.D. Chemistry Team Leader CDER/Office of New Drug Chemistry Co-Chair, Comparability.

Regulatory requirements on Medicine Stability Guidelines relevant for Stability testing Sultan Ghani.

Training Workshop on Pharmaceutical Development with a Focus on Paediatric Medicines / October |1 | Regulatory Requirement on Dossier of Medicinal.

PAT Validation Working Group Process and Analytical Validation Working Group Arthur H. Kibbe, Ph.D. Chair June 13, 2002.

ONDQA Perspective on Post Approval Changes Eric P. Duffy, PhD Director, Division of Post-Market Evaluation, ONDQA, CDER, FDA Public Meeting: Supplements.

1 ACPS November 15, Update Nancy B. Sager, Associate Director Office of Pharmaceutical Science Center for Drug Evaluation & Research Food and.

1 Revisions to 21 CFR Supplements and Other Changes to an Approved Application PhRMA Perspective FDA Public Meeting – 7 Feb 2007.

1 DRUG QUALITY SYSTEM FOR THE 21 ST CENTURY PQRI/FDA April CHANGES WITHOUT PRIOR APPROVAL AN FDA PERSPECTIVE Dennis M. Bensley, Jr., Ph.D. Center.

FDA’s Perspective Continued - Where We Are ?. GMP Task Groups.

Product Definition Chapter 4. What is a Medical Device? FDA: “an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent,

DRUG MASTER FILES / 45.

Executive summary prepared by some members of the ICH Q9 EWG for example only; not an official policy/guidance July 2006, slide 1 ICH Q9 QUALITY RISK MANAGEMENT.

Growth and Success through Partnering & Outsourcing.

What You Want to Know About Generic Drugs Generic Drugs: Safe. Effective. FDA-Approved.

Quality By Design - A Generic Industry Perspective

This communication does not constitute an offer to sell or the solicitation of an offer to buy any securities or a solicitation of any vote or approval.

IMPLEMENTATION ISSUES

Nonclinical Studies Subcommittee Advisory Committee for Pharmaceutical Science CMC Issues for Screening INDs Eric B. Sheinin, Ph.D. Acting Deputy Director.

ITFG/IPAC Collaboration CMC Specifications Technical Team ITFG/IPAC TECHNICAL TEAM: CMC SPECIFICATIONS Presented by: Bo Olsson, PhD 26 April 2000 Rockville,

Industry Perspective on Challenges for Product Developers - Drugs Christine Allison, M.S., RAC Associate Regulatory Consultant, Global Regulatory Affairs.

1 Supplements and Other Changes to an Approved Application By: Richard J. Stec Jr., Ph.D. February 7, 2007.

Ajaz S. Hussain, Ph.D. Deputy Director Office of Pharmaceutical Science, CDER, FDA ACPS Subcommittee on Manufacturing Science: Identification and Prioritization.

PRODUCT TRANSFER.

Clinical Trial Review and Approval: New Regulations and their implications Siddika Mithani, Ph.D Clinical Trials & Special Access Programme Therapeutic.

DMF Procedures and Communication between API, FP Manufacturers and Regulatory Authorities Jean-Louis ROBERT National Health Laboratory L – 1011 LUXEMBOURG.

1 CONSENSUS STANDARDS OIVD WORKSHOP April 22-23, 2003 Rockville MD Ginette Y. Michaud, M.D. OIVD.

1 PAT and Biological Products Tom Layloff FDA-SGE Management Sciences for Health The views expressed here are those of the author and not necessarily.

The Future of the Market Research Industry: An Insider’s Perspective Presented by: Don Mills President & CEO Corporate Research Associates Inc. June 11,

Quality by Design & Question-Based Review: Observations by the Generic Pharmaceutical Industry Advisory Committee for Pharmaceutical Science October 5,

Managing Risk Through Pharmaceutical Product Life Cycles Hosted and Sponsored by Novartis Institutes for Biomedical Research for HBA Boston Chapter February.

Overview of FDA's Regulatory Framework for PET Drugs

PhRMA Perspective on FDA Final Report FDA Advisory Committee on Pharmaceutical Sciences October 20, 2004 G.P. Migliaccio, Pfizer Inc.

The SNM Centralized IND & Clinical Trials Network Enabling Implementation Investigational & Approved PET Imaging in Large Multicenter Clinical Trials George.

Risk-Based CMC Review - OGD Perspective Gary J. Buehler, R.Ph. Director Office of Generic Drugs July 21, 2004 Advisory Committee for Pharmaceutical Science.

COMPARABILITY PROTOCOLUPDATE ADVISORY COMMITTEE FOR PHARMACEUTICAL SCIENCE Manufacturing Subcommittee July 20-21, 2004 Stephen Moore, Ph.D. Chemistry Team.

Our PatientsOur PeopleOur BusinessOur Community © 2008 Endo Pharmaceuticals. All Rights Reserved. Biosimilars 2009 Update Pending Legislation Review Pam.

Generic Industry’s Perspective on the New GMP Initiative May 21, 2003 Generic Pharmaceutical Association Kenneth Lavin, M.Sc. Director, Regulatory Compliance.

UPCOMING CHANGES TO IN-VITRO DIAGNOSTICS (IVDs) AND LABORATORY DEVELOPED TESTS (LDTs) REGULATIONS Moj Eram, PhD November 5, 2015.

1 Imaging Community Critical Need #1: Standardized and Harmonized Multisite Imaging George Q. Mills, MD, MBA Vice President, Medical & Regulatory Relations.

CTD Dossier Preparation K. Srikantha Reddy Sr

Progress in FDA’s Drug Product Quality Initiative Janet Woodcock, M.D. November 13, 2003.

1 Office of Pharmaceutical Science on Jon Clark FDA/CDER/OPS Associate Director for Policy Development.

General Aspects of Quality assessment of multisource interchangeable medicines Rutendo Kuwana Technical Officer, WHO, Geneva Training workshop: Assessment.

GMP- A Regulatory Perspective. Regulatory Perspective in entering Global Pharma Markets.

CDER / Office of Compliance ACPS October 5, 2006 Joseph C. Famulare Acting Deputy Director Office of Compliance CDER / FDA.

Comparability Protocols Nancy Sager Associate Director, QIS-Chemistry FDA/CDER/OPS.

Lawrence X. Yu, Ph.D. Director for Science Office of Generic Drugs, OPS, CDER, FDA ACPS Meeting, ACPS Meeting, Oct. 22, 2003 Office of Generic Drugs Research.

FDA PAT Sub-Committee of Advisory Committee for Pharmaceutical Sciences June 12-13, 2002; Gaithersburg, MD Regulatory Challenges: Post-Approval PAT Applications.

Drug Quality Regulations for the 21 st Century PhRMA Perspective Manufacturing Subcommittee Meeting – May 21, 2003 Gerry Migliaccio Pfizer Inc.

Examining Drug Quality Regulation Douglas C. Throckmorton, MD Deputy Director Center for Drug Evaluation and Research Public Meeting on 21 CFR February,

OVER 20 YEARS OF EXPERIENCE IN CHEMICAL AND PHARMA INDUSTRY

The Information Professional’s Role in Product Safety

Formal Meetings between FDA and Sponsors of PDUFA Products

Quality System.

HOW TO FULFILL STATUTORY REQUIREMENTS ON PRODUCT RELATED HEALTH INFORMATION Samina Qureshi, M.D. PSI INTERNATIONAL Inc.

Michael Gross, Ph.D., RAC Vice-President Worldwide Compliance

HOW INDUSTRIES CHANGE.

Presentation transcript:

Arthur Fabian, PhD February 7, 2007 FDA Public Meeting Rockville MD

SST Business Model Represent numerous API & Intermediate Manufacturers worldwide. Represent numerous API & Intermediate Manufacturers worldwide. Market and Sell APIs & Intermediates to both the Brand and Generic Industries in the US. Market and Sell APIs & Intermediates to both the Brand and Generic Industries in the US. Provides a unique Regulatory vantage-point. Provides a unique Regulatory vantage-point.

SST Regulatory Model Type II DMF Holder SST (A)NDA Sponsor API Manufacturers/Suppliers Customers

Industry Regulatory Model Type II DMF Holder (A)NDA Sponsor Historical Model for Generic Industry Historical Model for Generic Industry Widespread model (40%) for the Brand Industry due to Outsourcing Widespread model (40%) for the Brand Industry due to Outsourcing

SST’s Business Interest Maintain Supplier competitiveness. Maintain Supplier competitiveness. Introduce new synthetic methods, equipment, alternate sites, specifications, PAT techniques. Introduce new synthetic methods, equipment, alternate sites, specifications, PAT techniques. Encourage Change / Innovation. Encourage Change / Innovation. Same goal as Agency’s Quality Initiative. Same goal as Agency’s Quality Initiative.

Presentation Perspective Drug Substance & DMF Holder Drug Substance & DMF Holder rather than rather than Drug Product & (A)NDA Sponsor Drug Product & (A)NDA Sponsor

Presentation Topics Five Points to Consider in the revision Five Points to Consider in the revision Relevance of the Risk-Based Paradigm Relevance of the Risk-Based Paradigm “Outside the Box” Ideas “Outside the Box” Ideas

Point # 1

Point # 2

Separate Sections Requires authors to adopt a presently absent Drug Substance mindset. Requires authors to adopt a presently absent Drug Substance mindset. Filing recommendations for scale and equipment changes for small molecule APIs would be present. Filing recommendations for scale and equipment changes for small molecule APIs would be present. Change from Centrifugation to Filtration would not be a PAS.* Change from Centrifugation to Filtration would not be a PAS.* *Particle Design of APIs Through Crystallization, W.Beckmann, Schering AG, American Pharmaceutical Review, Vol 9, Issue 6, pg 110 & ff, Sept. ‘06

Point # 3

DMF Holders Filing mechanism format: Sponsor/DMF Holder Filing mechanism format: Sponsor/DMF Holder PAS/AM, CBE-0/AM, AR/AM. PAS/AM, CBE-0/AM, AR/AM. Expand the use of DMF Annual Update Expand the use of DMF Annual Update Minor Changes via AR/AU.Minor Changes via AR/AU. No additional documentation to FDA.No additional documentation to FDA.

Point # 4

Present Guidance All Process Changes after the Final Intermediate (FI) require a Pre-Approval Supplement !!

Final Step: Changes Guidance FI API FI API Last Step

Final Step: Science-Based Final Step: Science-Based FI CAPI PAPI FAPI FI CAPI PAPI FAPI ChemicalPurification Post Post Synthetic Operations* Synthetic Operations* * Drying, Milling, Micronization, Blending, Packaging CAPI: Crude API PAPI: Purified API FAPI: Final API

Final Step: Science-Based A FI Crude PAPI Change here Equivalence here steps PAS should not be necessary ! FAPI

Phased Approach Phased Approach FI CAPI PAPI Chemical Purification FAPI YesNoNo YesNoYes NoYesNo NoYesYes NoNoYes YesYesNo YesYesYes NoNo No, ie different FI No, ie different FI Post synthetic Operations

Chemical Phase Only Chemical Phase Only FI CAPI PAPI Yes No No Yes No No Chemical Purification Post synthesis FAPI Yes CBE/AM No Equivalent PAPI? PAPI? Yes CBE-30/AM PAS/AM Equivalent CAPI? CAPI? No

Purification Phase Only Purification Phase Only FI CAPI PAPI FAPI Chemical Purification Post Post synthesis synthesis EquivalentPAPI? CBE-30/AMPAS/AM YesNo No Yes No No Yes No

Post Synthesis Phase Only FI CAPI PAPI FAPI FI CAPI PAPI FAPI ChemicalPurification Post Post synthesis synthesis EquivalentFAPI? CBE-30/AM PAS/AM Yes No No No Yes No No Yes

Chemical & Purification Phases FI CAPI PAPI FAPI FI CAPI PAPI FAPI ChemicalPurification Post Post synthesis synthesis EquivalentPAPI? CBE-30/AM PAS/AM Yes No Yes Yes No Yes Yes No Yes/No EquivalentCAPI?

Chemical & Post synthesis Phases FI CAPI PAPI FAPI FI CAPI PAPI FAPI ChemicalPurification Post Post synthesis synthesis EquivalentPAPI? CBE-30/AM PAS/AM YesNo Yes No Yes Yes No Yes EquivalentCAPI? Yes/No Yes/No EquivalentFAPI?

Change in all Three Phases FI CAPI PAPI FAPI FI CAPI PAPI FAPI ChemicalPurification Post Post synthesis synthesis Equivalent PAPI? PAPI? CBE-30/AM PAS/AM Yes No Yes Yes Yes Yes Yes Yes EquivalentCAPI? Yes/No Yes/No EquivalentFAPI?

Change in no Phases: new FI FI’ CAPI PAPI FAPI FI’ CAPI PAPI FAPI Chemical Purification Post Post synthesis synthesis Equivalent PAPI? PAPI? CBE-30/AM PAS/AM Yes No No No No No No No EquivalentCAPI? No Yes Yes CBE-30/AM

Point # 5

Proposed Redefinition Major Process Changes Major Process Changes Must impact the API, not an upstream IntermediateMust impact the API, not an upstream Intermediate Proof of Equivalence needs supporting data beyond a specification comparison.Proof of Equivalence needs supporting data beyond a specification comparison. This definition amenable to Scale and Equipment Changes, but other factors need consideration. This definition amenable to Scale and Equipment Changes, but other factors need consideration. Site and Specification Changes need a different analysis. Site and Specification Changes need a different analysis.

Risk-Based Paradigm Risk-Based Paradigm FDA only pre-approves Changes affecting the API and requiring more complex equivalence data, ie, Major. FDA only pre-approves Changes affecting the API and requiring more complex equivalence data, ie, Major. Totally analogous to the Risk-Based Inspection Model. Totally analogous to the Risk-Based Inspection Model. Does not offer select companies reduction of filing mechanism; not needed. Does not offer select companies reduction of filing mechanism; not needed.

Outside the Box Ideas CBE 60/90 as Bridge to reducing PAS. CBE 60/90 as Bridge to reducing PAS. Special DMF Amendment for Changes; no link to (A)NDA Sponsor filing. Special DMF Amendment for Changes; no link to (A)NDA Sponsor filing. High Quality CMC Information, not high volume. High Quality CMC Information, not high volume.