Food and Drug
Administration
Clinical Pharmacology Subcommittee
of the
Advisory Committee for Pharmaceutical Science
October 18-19,
2006
Briefing
Information
FDA
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.
Executive Summary
(pdf)
Novaldex Sample Label
(pdf)
Guidance for Industry
Drug Interaction Studies-Study Design, Data Analysis, and
Implications for Dosing and Labeling (pdf)
Backgrounder by FDA Pharmacometrics (pdf)
Bibliography (pdf)
Additional References (pdf)