FDA Regulation of Drug Quality: New Challenges Janet Woodcock, M.D. Director, Center for Drug Evaluation and Research, Food and Drug Administration November.

Slides:

Advertisements

Similar presentations

U.S. Food and Drug Administration Notice: Archived Document The content in this document is provided on the FDAs website for reference purposes only. It.

Advertisements

The ACPS’s Process Analytical Technology Subcommittee

Steven D. Vaughn, DVM Director Office of New Animal Drug Evaluation Center for Veterinary Medicine U. S. Food and Drug Administration June 6, 2012 Embracing.

Maura Kinahan, PhD MPSI “Medicines Shortages - Industry Perspective” 2013 INTERNATIONAL SUMMIT ON MEDICINES SHORTAGE Toronto 20 th -21 st June 2013.

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

D. Christopher Watts, Ph.D. Office of Pharmaceutical Science, CDER, FDA ASQ/FDC October 22, 2004 Process Analytical Technology (PAT)

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

What’s New in the FDA’s Pharmaceutical Inspectorate and Risk Based Systems Inspection Rick Perlman Chair Food, Drug, and Cosmetic Division ASQ.

Perspectives on New Paradigms of Risk and Compliance in Pharmaceutical Development: Quality by Design, PAT, and Design Space David J. Cummings OPS Quality.

HTA from an Industry Perspective Janey Shin, Director of Medical Affairs Johnson & Johnson Medical Companies CADTH, 2015.

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

Pilot Risk-Ranking Model to Prioritize Manufacturing Sites for GMP Inspections Advisory Committee for Pharmaceutical Science Manufacturing Subcommittee.

Final Report on Process Analytical Technology (PAT) and Manufacturing Science Ajaz S. Hussain, Ph.D. Deputy Director, Office of Pharmaceutical Science,

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.

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

Validation perceptions that may slow PAT development and implementation Steve Hammond Pfizer Global Manufacturing.

Ensuring Physical Stability of Pharmaceuticals: Can/should we improve our ability to identify and prevent physical changes? Ajaz S. Hussain, Ph.D. Deputy.

Federal Financial Aid: Regulatory Burden and Future Direction – The Impact on Ability for Institutional Responsiveness to State Goals (Foresight 20/20)

Quality By Design - A Generic Industry Perspective

Achieving and Demonstrating “Quality-by-Design” with Respect to Drug Release/dissolution Performance for Conventional or Immediate Release Solid Oral Dosage.

Science at the FDA: Update for the Science Board Jesse L. Goodman, MD, MPH Chief Scientist and Deputy Commissioner for Science and Public Health November.

Mike Murray Chair of EFPIA EH&S AHG MPA Conference Uppsala

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

D. Christopher Watts, Ph.D. Office of Pharmaceutical Science, CDER, FDA Science Seminar Series for the Office of Commissioner April 9, 2004 Process Analytical.

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

Ajaz S. Hussain, Ph.D. Office of Pharmaceutical Sciences CDER, FDA October 21, 2003 Welcome and Introduction to the Meeting.

FDA Regulation of Drug Quality: New Challenges Janet Woodcock, M.D. Director, Center for Drug Evaluation and Research, Food and Drug Administration April.

Lecture Topic 4: Good Manufacturing Practices (GMPs)

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.

FDA’s Perspective on the “Pharmaceutical cGMPs for the 21st Century” Initiative David J. Horowitz, Esq. Director, CDER/FDA, Office of Compliance Advisory.

1 Regulatory Aspects of Pharmaceutical Excipients PQRI Workshop Nick Buhay Acting Director Division of Manufacturing and Product Quality Office of Compliance.

Office of Pharmaceutical Sciences

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

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

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.

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

Nanotechnology - USDA - 18 Nov 2002 REGULATORY CONSIDERATIONS FOR NANOTECHNOLOGY IN PUBLIC HEALTH FOOD AND DRUG ADMINISTRATION Norris E. Alderson, Ph.D.

1 Operation of the Prescription Drug User Fee Program Janet Woodcock, M.D. Deputy Commissioner for Operations November 14, 2005.

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

© G.K.Raju, Ph.D. Confidential FDA Manufacturing Subcommittee Meeting July 20, 2004 G.K. Raju, Ph.D. Executive Director, MIT/PHARMI Massachusetts Institute.

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

What HIT Policy Changes Will Mean for MedTech October 22, 2004 Blair Childs Executive Vice President, Strategic Planning & Implementation.

Pharmaceutical Manufacturing Subcommittee of the ACPS Ajaz S. Hussain, Ph.D. ACPS Meeting October 22, 2002.

ICH Quality Topics Update

Second Meeting of the FDA/ACPS Process Analytical Technology: Closing Remarks Ajaz S. Hussain, Ph.D. Deputy Director Office of Pharmaceutical Sciences.

FDA’s Advisory Committee for Pharmaceutical Science The Subcommittee on Process Analytical Technologies (PAT): Closing Remarks Ajaz S. Hussain, Ph.D. Deputy.

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,

FDA Advisory Committee for Pharmaceutical Science and Clinical Pharmacology July 22-23, 2008 Introduction and Update Helen N. Winkle Director, Office of.

IRB – Investigator/Research Coordinators Monthly Meeting Gerald D. Fischbach, M.D. Executive Vice President for Health and Biomedical Sciences and Dean.

FDA Facility Evaluation Douglas Stearn Deputy Director for Policy and Analysis Office of Compliance Center for Drug Evaluation and Research.

The Benefits of VICH to VICH Member Countries and Regions DONALD A. PRATER, DVM Director, U.S. FDA Europe Office Office of International Programs Office.

Establishment of Medical Device GMP Requirements Hsiau-Wen Huang, Ph. D. Senior Researcher Bureau of Pharmaceutical Affairs Department of Health.

The Interrelationship between PAT and Six Sigma

Pharmaceutical Quality in the 21st Century

Industrial Pharmacy.

CDRH 2010 Strategic Priorities

American Society for Quality Region 5 Quality Conference

Quality System.

The Interrelationship between PAT and Six Sigma

Harmonization for Patient Centered Universal Health Coverage

Fact: Standards Mean Business To industry, government and the bottom line

Lorem Ipsum lorem ipsum

Lorem Ipsum lorem ipsum

GMP Legal Framework in Kyrgyzstan

Approach: The Cuban Regulatory Strategy

Presentation transcript:

FDA Regulation of Drug Quality: New Challenges Janet Woodcock, M.D. Director, Center for Drug Evaluation and Research, Food and Drug Administration November 16, 2001

Regulation of Drug Quality: Current Status n n Pharmaceutical industry manufacturing sector highly regulated n n FDA review and approval of process, documentation, and facility required prior to approval n n Many process changes require FDA review and approval prior to institution n n Ongoing manufacturing subject to FDA inspection and GMP standards conformance

Current Status of System for Ensuring Drug Quality n n US Drug products are of high quality, BUT n n Increasing trend toward manufacturing-related problems – –Recalls – –Disruption of manufacturing operations – –Loss of availability of essential drugs – –Negative impact on new drug approvals

Current Status System for Ensuring Drug Quality, cont n n US drug products are of high quality, BUT n n Low manufacturing and QA process efficiency- -cost implications n n Innovation, modernization and adoption of new technologies slowed Introduction of new technologies in facilities not for US market

Current Status System for Ensuring Drug Quality, cont n n US Drug Products are of high quality, BUT n n High burden on FDA resources – –About 4,000 manufacturing supplements submitted yearly – –FDA inspectors unable to meet statutory biennial GMP inspection requirement – –Lower scrutiny of non-domestic industry

How Did We Get Here? n n System evolved beginning years ago--when sectors of industry lacked rigorous SOPs n n Science/technology base did not evolve as quickly as in other sectors

How Did We Get Here? (CONT) n n GMP standards are empirical, not science based n n International conference on Harmonization--consensus based standards (1990’s) n n Industry--regulatory risk averse

The Discovery-Development- Manufacturing Challenge n The drug discovery revolution –identification of promising new molecular entities for development is not “rate-limiting” n Significant ongoing efforts to improve drug development processes –minimize high attrition rates n Need for innovation in manufacturing process R&D –significant, long-term, impact on public health and industry

Challenges for FDA n n How to encourage innovation while ensuring high quality – –Successful adoption of new technologies will IMPROVE overall quality n n How to successfully shift from empirical to science based standards for manufacturing process quality

Challenges for FDA n n How to decrease reliance on pre-approval review and physical evaluation n n How to recruit and train a scientific workforce proficient in application of new technologies

Today’s Approach n n Presentation of Problem from variety of perspectives n n Use of PAT as an EXAMPLE of new technology

Speakers n n Doug Dean and Frances Bruttin (PricewaterhouseCoopers, Pharmaceutical Sector Team) n n G. K. Raju (Executive Director, MIT’s Pharmaceutical Manufacturing Initiative) n n Norman Winskills (Vice President Global Manufacturing Services, Pfizer) and Steve Hammond (Manager, Process Analytical Support Group, Pfizer) n n Ajaz Hussain (FDA Deputy Director, Office of Pharmaceutical Science) - Regulatory perspective on new scientific approaches

Questions for the Science Board n n Are you able to support the approach? n n What resources do you suggest FDA draw on? n n Are there additional aspects to regulation of pharmaceutic quality that we should focus on?