ORALLY INHALED AND NASAL DRUG PRODUCTS SUBCOMMITTEE
OF THE ADVISORY COMMITTEE FOR PHARMACEUTICAL SCIENCE
July 17, 2001
Singh, Gur Jai Pal. An Update from the Food and Drug Administration - One year on from the new guidance. Presented at the Management Forum's Second Annual Conference, 13-14 November 2000, Claridges, London, England.
Proceedings of the Orally Inhaled and Nasal Drug Products Subcommittee of the Advisory Committee for Pharmaceutical Science. April 26, 2000. Transcript pp. 182-194. "In Vivo BA and BE Clinical Studies for Local Delivery of Nasal Aerosols and Sprays."
Roman, Izabela J. Clinical studies for local delivery of nasal aerosols and sprays. Presented at the Orally Inhaled and Nasal Drug Products Subcommittee of the Advisory Committee for Pharmaceutical Science, April 26, 2000. Rockville, MD.
Adams, W. P., et al. "Nasal Inhalation aerosols and metered dose spray pumps: FDA bioequivalence issues." Presented at Respiratory Drug Delivery VI, May 3-7, 1998, Hilton Head South Carolina.
The European Agency for Evaluation of Medicinal Products, Human Medicines Evaluation Unit. Clinical requirements for locally applied, locally acting products, containing know constituents. EMEA status as of 11/95.
CDER Guidance for Industry, Bioavailability and bioequivalence studies for nasal aerosols and nasal sprays for local action, Draft Guidance, June 1999.
CDER Guidance for Industry. Allergic rhinitis: Clinical development programs for drug products. Draft Guidance, April 2000.