ADVISORY COMMITTEE FOR PHARMACEUTICAL SCIENCE
November 15, 2000
University of Maryland, Shady Grove Campus
9640 Gudelsky Drive
Rockville, MD
Backgrounder Contents
Attendees
Invited Guests and Speakers pdf doc
Federal Register Notice – November 15, 2000 Subcommittee Meeting pdf htm
Chemistry, Manufacturing, and Controls
Reducing the Regulatory Burden pdf doc
Subcommittee Reports:
Orally Inhaled and Nasal Drug Products pdf doc
Draft Guidance for Industry: Metered Dose Inhaler and Dry Powder Inhaler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Draft Guidance for Industry: Nasal Spray and Inhalation Solution, Suspension,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Draft Guidance for Industry: Bioavailability and Bioequivalence Studies for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)