March 13, 2003
Briefing Information
Rapid Response Fact Sheet, FDA (HTM) (PDF) (Word)
Does Content Uniformity - Parametric Tolerance Interval Test for Aerosol Products (PDF)
Metered Dose Inhaler (MDI) and Dry Powder Inhaler (DPI) Drug Products Guidance for Industry (PDF)
Nasal Spray and Inhalation Solution, Suspension, and Spray Drug Products - Chemistry, Manufacturing and Controls Documentation Guidance for Industry (PDF)
Disclaimer
The statements contained in this document(s) are those of the product's sponsor, not FDA, and FDA does not necessarily agree with the sponsor's statements. FDA has not made a final determination about the safety or effectiveness of the product described in this document.
Briefing Information Regarding Levothyroxine Bioequivalence, Abbott Laboratories (HTM) (PDF) (Word)
Appendix A - Study M02-417 Synopsis and Discussion, Abbott Laboratories (HTM) (PDF) (Word)
Evaluation of Bioequivalence and Efficacy of L-thyroxine Preparations in the Treatment of Human Thyroid Disease (PDF)
Open Public Hearing
Statement of Dr. Lawrence Wood, MD Regarding Levothyroxine Bioequivalence (PDF)
American Thyroid Association Statement Review of Bioequivalence for levo-thyroxine products (PDF)
The Need for Precise L-Thyroxine Dosing, Dr. James Hennessey, MD, Brown University (PDF)
Impact of T4 Dose on Babies with Congenital Hypothyroidism, Rosalind Brown, Children's Hospital, Boston (PDF)
Statement of Dr. Leslie DeGroot, MD, University of Chicago (PDF)
Statement of dr. Jerome Hershman, MD, University of California (PDF)
Statement of Dr. Omega Silva, MD, FACP (PDF)
Evaluation of the Efficacy of Different L-thyroxine Preparations in the Treatment of Human Thyroid Disease, Dr. Irwin Klein, MD, NYU School of Medicine (PDF)
Statement of Dr. Richard Dickey, MD, The Endocrine Society (PDF)
Statement of Joan Shey (PDF)
Statement of Dr. H. Baskin, MD, MACE, Florida Thyroid & Endocrine Clinic (PDF)
Presentation by Sanford Bolton, Geneva Pharmaceuticals (PDF)
Statement of Lewis Braverman, MD, Boston Medical Center (PDF)
Questions to the Panel from Roxane Laboratories (PDF)