1 Update on Nanotechnology Activities in CDER and FDA Keith O. Webber, Ph.D. Deputy Director OPS/CDER/FDA ACPS Meeting Tuesday, July 22, 2008.

Slides:

Advertisements

Similar presentations

Ramana S. Uppoor, M.Pharm., Ph.D., R.Ph.

Advertisements

Food Advisory Committee Meeting Risk assessments and susceptible life stages and populations December 16, 2014 Rachel Osterman Associate Chief Counsel,

Canada/Australia Issues being faced in the regulation of nano-materials Deborah Willcocks – Department of Health and Ageing, Government of Australia Anne-Marie.

© 2004 Prof Roland Clift NANOTECHNOLOGY Professor Roland Clift, Centre for Environmental Strategy, University of Surrey, GUILDFORD, Surrey GU2 7XH, UK.

Strengthening the Medical Device Clinical Trial Enterprise

The ICH E5 Question and Answer Document Status and Content Robert T. O’Neill, Ph.D. Director, Office of Biostatistics, CDER, FDA Presented at the 4th Kitasato-Harvard.

"Informational needs and the regulatory frame for consumer applications: The EU Commission's view" Philippe Martin European Commission Directorate-General.

What Do Toxicologists Do?

Cancer Nanotechnology: New Opportunities for Targeted Therapies FDA Public Meeting October 10, 2006 Piotr Grodzinski, Ph.D. Director, Nanotechnology for.

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

FDA’s Policy for Evaluating Bioengineered Foods Jeanette Glover Glew Food and Drug Administration Center For Food Safety and Applied Nutrition September,

ACPS October Nanotechnology: Issues and Future Directions Nakissa Sadrieh Ph.D. OPS/CDER/FDA.

Ohio Nano-Summit March 3, 2005 REGULATORY CONSIDERATIONS FOR NANOTECHNOLOGY IN PUBLIC HEALTH FOOD AND DRUG ADMINISTRATION Norris E. Alderson, Ph.D. Associate.

DSHEA and Bioavailability Elizabeth A. Yetley, Ph.D. Ctr. Food Safety & Applied Nutrition Food and Drug Administration.

N ANOPARTICLES IN BIOLOGY AND MEDICINE Antti Rautiainen KE Nanopartikkelit.

Animal Feed GRAS Notifications Geoffrey K. Wong, M.S. Division of Animal Feeds Center for Veterinary Medicine Pet Food Institute Pet Food Institute October.

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

1 OECD Work on the Safety of Manufactured Nanomaterials Environment, Health and Safety Division Environment Directorate OECD.

FDA Considerations For Regulation Of Nanomaterial Containing Products

Ashland Specialty Ingredients IFAC’s cGMP Audit Guide How the Food Ingredient Industry has Responded to FSMA and Food Safety Audits Priscilla Zawislak.

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

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

1 FDA Perspective on Nanomaterial- Containing Products Nakissa Sadrieh, Ph.D. Office of Pharmaceutical Science Center for Drug Evaluation and Research.

Nanotechnology Summary. Potential Worker Exposures.

Stakeholders In Clinical Research Government and Regulatory Bodies Professor Phil Warner.

Regulatory Approach to Novel Nanomaterials: Unique Benefits Versus Unique Risks Russ Lebovitz, MD, PhD SUMA Partners October 6, 2006.

NCI Review of the Clinical Trials Process 6 th Annual National Forum on Biomedical Imaging in Oncology James H. Doroshow M.D. April 7, 2005 Bethesda, Maryland.

Nanomaterials Issue Paper Standard 61 Joint Committee Meeting December, 2013.

INTRODUCTION TO RA.

1 International/OECD Nanotechnology Activities EPA/DoD Meeting on Nanotechnology March 9, 2007 Jim Willis, EPA/OPPT.

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

REGULATORY CHALLENGES FOR NANOMATERIALS IN PUBLIC HEALTH Driving Faster Than Our Nano-Headlights AAAS Annual Meeting February 13, 2009 Norris E. Alderson,

OECD Work on the Safety of Manufactured Nanomaterials Environment, Health and Safety Division Environment Directorate OECD October

FDA’s Role in Encouraging Innovation in Combination Products Danelle R. Miller, Esq. Regulatory Counsel, Roche Diagnostics For The Combination Products.

World Congress on Safety and Health at Work Korea Promoting Safe Use of Nanotechnologies in Australian Workplaces: Nanotechnology OHS Research and.

Forging Partnerships on Emerging Contaminants November 2, 2005 John Vandenberg Associate Director for Health National Center for Environmental Assessment.

NANOTECHNOLOGIES: THE NEW GENERATION OF MEDICINE Dr Mariano Licciardi.

Nanotechnology in Cancer Treatment

Presented to: Transport Airplane Metallic and Composite Structures Working Group and Airworthiness Authorities By: Walt Sippel and Mike Gruber Date: Sept.

1 FDA Perspective on Nanomaterial- Containing Products Nakissa Sadrieh, Ph.D. Associate Director for Research Policy and Implementation Office of Pharmaceutical.

1 Risk Governance of Manufactured Nanoparticles, Joint Workshop EP STOA Panel – European Commission, Brussels, 21 November 2011 Interfaces between Science.

Nano-materials: Environmental and Health Impacts Chem Eng Progress: 104 (12), , 2008.

Center for the Environmental Implications of Nanotechology Program Solicitation NSF Preliminary Proposal Due: December 10, 2007 National Science.

CDER Drug Safety Oversight Board Douglas C. Throckmorton, M.D. Deputy Director, CDER Food and Drug Administration November 5, 2005.

Key Research Questions: The University of Wisconsin – Madison Nanoscale Science and Engineering Center Social, Legal and Environmental Impacts of Engineered.

DESIGNING A PROGRAM FOR REVIEW OF CDER LABORATORY RESEARCHERS Keith Webber, Ph.D. Acting Deputy Director OPS/CDER/FDA.

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

1 OSHA’s Approach to Nanotechnology: Developing a Searchable "Health Effects Matrix" Database for Nanomaterials Utilizing Existing Published Data Janet.

UPDATE: Nonclinical Reproductive Toxicity Information in Assessing Human Risk Joseph J. DeGeorge Ph.D. Associate Director for Pharmacology and Toxicology.

1 Nanoscale Materials Stewardship Program Environmental Summit May 20, 2008 Jim Alwood Chemical Control Division Office of Pollution Prevention and Toxics.

Research in the Office of Vaccines Research and Review: Vision and Overview Jesse Goodman, M.D., M.P.H. Director, Center for Biologics Evaluation and Research.

1 Drug Safety Oversight Board: Recent Activities FDA Science Board Advisory Committee Meeting March 31 st, 2006 Douglas C. Throckmorton, MD Deputy Director.

Introduction to the Meeting Introduction to the Meeting Advisory Committee for Pharmaceutical Sciences Clinical Pharmacology Subcommittee November 17-18,

Bioavailability of Dietary Supplements: Key Issues in Defining the Research Agenda Impact of Formulation on Bioavailability? Discussion Leader: Stephen.

Research in the Office of Cellular, Tissue and Gene Therapies: Vision and Overview Jesse Goodman, M.D., M.P.H. Director, Center for Biologics Evaluation.

The Ministry of Science, Technology and Innovation

Bioequivalence Criteria Research Plan Stella G. Machado, Ph.D. Office of Biostatistics and the Replicate Design Technical Committee Advisory Committee.

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.

Center for Biologics Evaluation and Research, FDA Site Visit Introduction Kathryn M. Carbone, M.D. Associate Director for Research.

FDA Risk Communication Nancy M. Ostrove, PhD Senior Advisor for Risk Communication Risk Communication Advisory Committee February 28, 2008.

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.

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

Nanosafety ISO TC 229 Nanotechnologies Standardization in the field of nanotechnologies that includes either or both of the following:  1. Understanding.

Overview of the CPSC Directorate for Health Sciences * Mary Ann Danello, Ph.D. Associate Executive Director * The views expressed in this presentation.

FDA’s Role in the Risk Management of Opiate Analgesics Steven Galson, M.D., M.P.H. Deputy Center Director, Center for Drug Evaluation and Research Food.

Balancing Regulation and Innovation: An FDA Division of Cardiovascular Devices Perspective Bram Zuckerman, MD, FACC Director, FDA Division of Cardiovascular.

Regulatory Considerations for Coronary Drug Coated Balloons – FDA View

Regulatory Approach to Novel Nanomaterials: Unique Benefits Versus Unique Risks Russ Lebovitz, MD, PhD SUMA Partners October 6, 2006.

Nanotechnology: Issues and Future Directions

Presentation transcript:

1 Update on Nanotechnology Activities in CDER and FDA Keith O. Webber, Ph.D. Deputy Director OPS/CDER/FDA ACPS Meeting Tuesday, July 22, 2008

2 Purpose of this Session  Update the ACPS on CDER’s nanotechnology-related activities  Familiarize the committee with some pharmaceutically-relevant nanotechnology concerns  Receive advice from the ACPS on the regulation of nanotechnology drugs

3 Outline  Background Nanoparticles in drug products Impact on product evaluation in CDER  FDA Nanotechnology Task Force Report Summary Recommendations Public Meetings  CDER initiatives Development of database of products Research MaPP (?) Guidance (?)

4 polymeric biodegradable nanoparticles ceramic (inorganic) nanoparticles polymeric micelles (amphililic block copolymers) liposomes dendrimers nanocrystals (Quantum dots) for diagnostics applications and imaging magnetic nanoparticles (iron oxide for MRI) Nanoscale materials of potential use in drugs Sahoo and Labhasetwar, DDT, 2003  polymeric biodegradable nanoparticles  ceramic (inorganic) nanoparticles  polymeric micelles  Liposomes  Dendrimers  nanocrystals (Quantum dots) for diagnostics applications and imaging  magnetic nanoparticles (iron oxide for MRI)

5 Potential Pharmaceutical Applications of Nanotechnology  Targeted therapies Increase delivery to site of action Decrease systemic exposure  Multifunctional particles  Novel dosage forms Transdermal delivery Carrier function Controlled or sustained release  Protection of drug from degradation  Enhanced bioavailability

6 Evaluating Nanotechnology Products  Product quality assessment studies Characterization Quality control Manufacturing  Product safety assessment studies Biodistribution Clearance Metabolism Toxicology

7 CDER Nanotechnology Products  Sunscreens Nanoscale TiO2 and ZnO  Reformulations of previously approved products Nanoemulsions Nanocrystal colloid dispersions

8 The FDA Nanotechnology Task Force Focus:  Enable development of safe and effective products  Address knowledge or policy gaps  Guide science and technology  Assess current state of science  Strengthen collaboration with federal agencies

9 Task Force Report: Bottom Lines 1. Nanoscale materials could be used in most types of products regulated by FDA. 2. Nanoscale materials present challenges similar to other emerging technologies. 3. The fact that safety and efficacy can vary with size adds an additional level of complexity. 4. It is not apparent that nanoscale materials, as a group, have more inherent hazard than other materials. 5. Steps should be taken to better inform FDA reviewers and industry about what is known, needed, and expected.

10 Identification of Products Containing Nanomaterials Recommendation:  Issue guidance recommending that sponsors identify particle size of small particle materials in FDA-regulated products

11 Product Safety and Effectiveness Recommendations  Issue calls for safety and effectiveness data  Issue guidance on Manufacturing GRAS (“generally recognized as safe”) food ingredients Food and color additives Devices Cosmetics Dietary supplements

12 Labeling Recommendation Address on a product-by-product basis whether labeling must or may contain information on the use of nanomaterials

13 Public Meetings  Nanotechnology Materials in FDA- Regulated Products (October 2006)  Alliance for NanoHealth (March 2008)  FDA-wide meeting (September 2008) Focus on center-specific issues CDER will focus mainly on characterization, instrumentation, and manufacturing

14 CDER Nanotechnology Initiatives: Policy  Develop a database of drugs To identify data gaps (e.g., particle size information) Tracking  Develop a MaPP to capture relevant information in reviews.

15  Collaborators: NIST, NCL/NCI, CDRH  Dermal penetration of nanoparticles in sunscreens in minipigs.  Characterization of nanoparticles in marketed sunscreens (to address Citizen Petition).  Toxicity of select nanoparticles; correlation of in vitro findings with in vivo results. CDER Nanotechnology Initiatives: Research

16 CDER Nanotechnology Initiatives: Future Plans  Develop a definition, if deemed necessary  Identification of areas that require guidance development  Development of guidance documents, if needed.

17 Today’s Presentations  Larry Tamarkin (CytImmune Sciences)  Stephen Ruddy (Elan Corp.)  Darin Furgeson (Univ. of Wisconsin)

18 Questions for the Committee  Is specific CDER guidance needed for the development of nanotechnology derived drug applications?  If guidance is needed from CDER, what areas should these guidances focus on?  For regulatory purposes, what elements or factors should CDER consider incorporating into a definition of nanotechnology?