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Food and Drug
Administration
Advisory
Committee for Pharmaceutical Science
October 5-6,
2006
FDA Briefing
Information
Disclaimer
Portions
of this document have been determined to be exempt from disclosure
under the Freedom of Information Act (the FOIA) (5 U.S.C.
§552).
These redacted portions will appear as white space on
the screen or on the printed page.
Table of Contents for FDA Backgrounder
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The bioequivalence of highly variable
drugs and drug products -- K. Midha, Ph.D. (see Bibliography)
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- Critical Path
Opportunities List
- Critical
Path Initiative Fact Sheet
- Topical Drug Classification
-- L. Buhse, Ph.D., et. al., (see Bibliography)
- Pharmaceutical
Nomenclature Issues and Challenges -- M. Nasr, Ph.D.,
excerpted presentation, ACPS, October 2003
- CDER
Data Standards Manual Definitions for Topical Dosage Forms
- FDA
Considerations for Regulation of Nanomaterial Containing
Products -- N. Sadrieh, Ph.D., presentation
- Nonomaterials Raise
New Challenges (see Bibliography)
- FDA News: FDA Forms
Internal Nanotechnology Task Force
- Nanotechnology
public meeting -
Federal Register Notice
- Applicability of Existing
Regulations to the Development of a Dendrimer Nanotechnology-based
Pharmaceutical (Summary) -- J. Paull, Ph.D.
- Regulatory Approaches
To Novel Nonomaterials -- M. Lebovits, Ph.D.
- Bibliography
Page last updated
September 19, 2006
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