Food and Drug Administration

Pharmaceutical Science Advisory Committee

March 12, 2003

Briefing Information

February 11, 2003 Cover Letter From Helen Winkle, FDA (HTM) (PDF) (Word)

Errata to February 11, 2003 Cover Letter from Helen Winkle (HTM) (PDF) (Word)

Bibliography, FDA (HTM) (PDF) (Word)

Topical Dosage Form Classification, FDA (HTM) (PDF) (Word)

CDER Data Standards Manual, FDA (PDF)

Decision Tree on Topical Dosage Form Nomenclature, FDA (HTM) (PDF) (Word)

Definitions of Topical Dosage Forms, FDA (HTM) (PDF) (Word)

Comparability Protocols--Chemistry, Manufacturing, and Controls Information Guidance for Industry, FDA (PDF)

Additional Information (HTM) (PDF) (Word)

Levothyroxine Bioequivalence, Abbott Labortories (HTM) (PDF) (Word)

Appendix A - Abbott Laboratories Study M02-417 Synopsis and Discussion (HTM) (PDF) (Word)