ADVISORY COMMITTEE FOR PHARMACEUTICAL SCIENCE

November 15, 2000

University of Maryland, Shady Grove Campus
9640 Gudelsky Drive
Rockville, MD

Backgrounder Contents

Agenda  pdf  doc

Attendees

Committee Membership pdf doc

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

Questions 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Draft Guidance for Industry: Metered Dose Inhaler and Dry Powder Inhaler (DPI)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Draft Guidance for Industry: Nasal Spray and Inhalation Solution, Suspension,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Draft Guidance for Industry: Bioavailability and Bioequivalence Studies for Nasal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)

Nonclinical Studies  pdf  doc