IPAC-RS comments on "Concept paper on revision of the guideline on the requirements for clinical documentation for orally inhaled products (OIP) including the requirements for demonstration of therapeutic equivalence between two inhaled products for use in the treatment of asthma and chronic obstructive pulmonary disease (COPD) in adults and for the treatment of asthma in children and adolescents"
IPAC-RS comments on the EMA "Concept paper on the revision of the guideline on the pharmaceutical quality of inhalation and nasal products"
IPAC-RS comments on the "Concept paper on developing a guideline on Quality requirements of medicinal products containing a device component for delivery or use of the medicinal product”
IPAC-RS Comments on EMEA Recommendation on the Need for Revision of (CHMP) Points to Consider on the Requirements for Clinical Documentation for Orally Inhaled Products (OIP)
IPAC-RS Comments on a Note for Guidance on Requirements for Pharmaceutical Documentation for Pressurised Metered Dose Inhalation Products (CPMP/QWP/2845/00) version released for consultation Nov. 2000
IPAC-RS Comments on the Health Canada Draft Guideline for corticosteroid products used in the treatment of asthma
IPAC-RS Comments on the Draft MHRA “Human Factors and Usability Engineering – Guidance for Medical Devices Including Drug-device Combination Products".
IPAC-RS Comments to FDA the Draft Guidance for Industry and Food and Drug Administration Staff on “Established Conditions: Reportable CMC Changes for
Approved Drug and Biologic Products"
IPAC-RS Device Working Group Comments to FDA
IPAC-RS Comments on USP Stimulus Article “Proposals for Data Interpretation in the Context of Determination of Aerodynamic Particle Size Distribution Profile for Orally Inhaled Products.”
IPAC-RS OINDP Materials Working Group comments on USP 1661 Evaluation of Plastic Packaging Systems and Their Materials of Construction with Respect to Their User Safety Impact.
OINDP Materials Working Group Comments to USP
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