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Food and Drug Administration

Advisory Committee for Pharmaceutical Science

October 5-6, 2006

FDA Briefing Information

Portions of this document have been determined to be exempt from disclosure under the Freedom of Information Act (the FOIA) (5 U.S.C. ß552). These redacted portions will appear as white space on the screen or on the printed page.

Table of Contents for FDA Backgrounder

  1. The bioequivalence of highly variable drugs and drug products -- K. Midha, Ph.D. (see Bibliography)
  1. Critical Path Opportunities List
  2. Critical Path Initiative Fact Sheet
  3. Topical Drug Classification -- L. Buhse, Ph.D., et. al., (see Bibliography)
  4. Pharmaceutical Nomenclature Issues and Challenges -- M. Nasr, Ph.D., excerpted presentation, ACPS, October 2003
  5. CDER Data Standards Manual Definitions for Topical Dosage Forms
  6. FDA Considerations for Regulation of Nanomaterial Containing Products -- N. Sadrieh, Ph.D., presentation
  7. Nonomaterials Raise New Challenges (see Bibliography)
  8. FDA News: FDA Forms Internal Nanotechnology Task Force
  9. Nanotechnology public meeting -  Federal Register Notice
  10. Applicability of Existing Regulations to the Development of a Dendrimer Nanotechnology-based Pharmaceutical (Summary) -- J. Paull, Ph.D.
  11. Regulatory Approaches To Novel Nonomaterials -- M. Lebovits, Ph.D.
  12. Bibliography

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