IPAC-RS COMMENTS TO EMEA GUIDANCES

IPAC-RS Comments on the Committee for Proprietary Medicinal Products’ (CPMP) draft  Note for Guidance on Requirements for Pharmaceutical Documentation for Pressurized Metered Dose Inhalers
IPAC-RS Comments on the EMEA Recommendation for revision of CPMP/EWP/4151/00 (requirements for clinical documentation for orally inhaled products).

IPAC-RS Comments on the Health Canada Draft Guideline for corticosteroid products used in the treatment of asthma.

IPAC-RS Comments on the Health Canada Draft Guideline for nasal products.

Joint paper by IPAC-RS and EPAG regarding draft ISO standard for aerosol drug delivery devices.
IPAC-RS Comments on the Uniformity of Dosage Units proposal by the ICH/Pharmacopeial Discussion Group.

IPAC-RS Comments to 2003 Draft BA/BE Nasal Sprays Guidance
IPAC-RS Comments to Draft Guidance on Inhalation Drug Products Packaged in Semipermeable Containers
IPAC-RS Comments to MDI/DPI CMC Draft Guidance
IPAC-RS Comments to Nasal Spray CMC Draft Guidance
IPAC-RS Comments to 1999 Draft BA/BE Nasal Sprays Guidance
IPAC-RS Statement at AAPS/FDA June 1999 Workshop

July 2001 OINDP Subcommittee and Advisory Committee for Pharmaceutical Science Meetings
            Written Statement
            Slide Presentation to OINDP Subcommittee
            Slide Presentation to Advisory Committee for Pharmaceutical Science
15 November 2000 Advisory Committee for Pharmaceutical Science Meeting
            Written Statement
            Slide Presentation to Advisory Committee
26 April 2000 OINDP Subcommittee Meeting
            Written Statement
            Slide Presentation to Subcommittee