IPAC-RS COMMENTS TO THE US FDA
PRIOR TO 2017
HF Studies and Related Clinical Study Considerations in Combination Product Design and Development
April 29, 2016
Docket #: FDA–2015–D–4848
Established Conditions: Reportable CMC Changes for Approved Drug and Biologic Products
July 31, 2015
Docket #: FDA-2015-D-1659
Draft Guidance on Current Good Manufacturing Practice Requirements for Combination Products
April 28, 2015
Docket #: FDA-2015-D-0198-0004
Applying Human Factors and Usability Engineering to Optimize Medical Device Design
January 01, 2011
Docket #: FDA-2011-D-0469
Bioavailability and Bioequivalence Studies for Nasal Aerosols and Nasal Sprays for Local Action
July 24, 2003
Docket #: 99D-1738
Inhalation Drug Products Packaged in Semipermeable Container Closure Systems
November 24, 2002
Docket #: 02D-0254
Bioavailability and Bioequivalence Studies for Nasal Aerosols and Nasal Sprays for Local Action
November 30, 1999
Nasal Spray and Inhalation Solution, Suspension, and Spray Drug Products CMC Documentation
August 31, 1999
Docket #: 99D-1454
Metered Dose Inhaler (MDI) and Dry Powder Inhaler (DPI) Drug Products CMC Documentation
February 17, 1999
Docket #: 98D-0997