NANOTECHNOLOGY: An Awareness Topic

1
NANOTECHNOLOGY An Awareness Topic

• Advisory Committee
• for
• Pharmaceutical Science
• April 14, 2004
• Nakissa Sadrieh, Ph. D.

2
Why the Interest?

• Rapidly growing area of science
• Anticipated to lead to the development of novel
  and sophisticated applications in drug delivery
  systems
• Private sector, academic centers and federal
  agencies are developing substantial programs in
  nanotechnology
• Significant research dollars being invested in
  nanotechnology

3
Nanotechnology Regulatory Dimensions

• Nomenclature
• Quality
• Safety
• Facility/Environmental

4
Nomenclature

• Defining nomenclature criteria
• Developing definition
• Identifying potential nanotechnology
  applications to CDER

5
Quality Dimension

• Characterization of nanomaterials
• Critical attributes
• Stability assurance
• Manufacturing and controls
• Drug release and bioequivalence testing

6
Safety and Environmental Assessment

• Pharmacology and toxicology challenges
• Current required studies adequate
• Are new testing models needed?
• In vitro models
• In vivo models
• Environmental
• Facility design
• Impact of nanotechnology products in the
  environment

7
CDER Meets the Challenge

• Creation of a multidisciplinary working group
• to identify regulatory challenges related to
  timely scientific assessment of drug and
  drug-device combination products
• To propose solutions to overcome challenges
• Members from
• OPS, OND, ONDC, OGD, OTC, OCPB
• One member from OC to maintain connection with OC
  interest group

8
CDER Working Group

• Goals and Objectives
• Definition and terminology
• Develop position papers (White Paper)
• Identify and propose development of regulatory
  guidance documents
• Identify training and research needs
• Coordination and collaboration