ORALLY INHALED AND NASAL DRUG PRODUCTS SUBCOMMITTEE OF

THE ADVISORY COMMITTEE FOR PHARMACEUTICAL SCIENCE

April 26, 2000

Briefing Information

FDA OINDP Working Groups List ppt htm

Federal Register Notice - April 26, 2000 Subcommittee Meeting pdf txt

OINDP Expert Panel Planning Meeting November 8, 1999 Minutes

Questions

AAPS Workshop on Regulatory Issues Related to Drug Products for Oral Inhalation and Nasal Delivery Slide Presentations:

FDA Nasal BA/BE Guidance Overview, Wallace P. Adams, Ph.D. ppt htm

Pharmacodynamic Testing for Orally Inhaled Drugs: Corticosteroids, Staffan Edsbacker, PhD ppt htm

Clinical Efficacy Testing for Nasal Drugs, Mary M. Fanning, Ph.D. ppt htm

Clinical Efficacy Testing for Orally Inhaled Drugs, Robert Meyer, M.D. ppt htm

Pharmacokinetic Testing for Systemic Exposure of Orally Inhaled and Nasal Drugs, Venkata Ramana Uppoor, M.Pharm., Ph.D., R.Ph. ppt htm

Content Uniformity for Inhalation Drug Products, Guirag Poochikian, Ph.D.

Adams WP, Singh GJP, Williams RL. Nasal Inhalation Aerosols and Metered Dose Spray Pumps: FDA Bioequivalence Issues, Program and Proceedings, Respiratory Drug Delivery VI, Interpharm Press, Buffalo Grove IL, 1998, pp. 219-25.

Draft Guidance for Industry: Metered Dose Inhaler and Dry Powder Inhaler (DPI) Drug Products (October 1998)

Draft Guidance for Industry: Nasal Spray and Inhalation Solution, Suspension, and Spray Drug Products (May 1999)

Draft Guidance for Industry: Bioavailability and Bioequivalence Studies for Nasal Aerosols and Nasal Sprays for Local Action (June 1999)

Comments for

Docket Number 99D-1738 Bioavilability & Bioequivalence Studies for Nasal Aerosols