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IPAC-RS COMMENTS

CHINA'S AGENCIES
China Comments
Brazil
EMA
EUROPEAN COMMISION
HEALTH CANADA
ISO AND ICH

THE MEDICINES AND HEALTHCARE PRODUCTS REGULATORY AGENCY (MHRA)

Post Transition Regulations in the UK

October 23, 2020

The Application of Analytical Quality by Design Concepts to Pharmacopoeial Standards for Medicines

August 28, 2019

Docket #: AQbD 2019

Human Factors and Usability Engineering

August 04, 2016

MHRA
USFDA

US FOOD AND DRUG ADMINISTRATION (FDA)

 

IPAC-RS Comments on FDA Draft Guidance "Essential Drug Delivery Outputs for Devices Intended to Deliver Drugs and Biological Products"

September 20, 20024

Docket#: FDA-2024-D-2560

 

​IPAC-RS Comments on FDA Draft Guidance: “Purpose and Content of Use-Related Risk Analyses for Drugs, Biological Products, and Combination Products - Guidance for Industry and FDA Staff” 
September 6, 2024

Docket#: FDA-2024-D-2484-0013

IPAC-RS Comments on Draft FDA Guidance for Industry “Statistical Approaches to Establishing Bioequivalence”

February 2, 2023

Docket#: FDA-2001-D-0197

IPAC-RS Comments on ICH Q12: Implementation Considerations for FDA-Regulated Products 

July 19, 2021

Docket #: FDA-2021-D-0166

IPAC-RS Comments on FDA EUA Draft Guidance 2020

June 22, 2020

Docket #: FDA-2019-D-5573

IPAC-RS Response to FDA Comments on USP Stimuli Article AIM EDA

September 09, 2019

Docket #: REF: 09-18-022-J

IPAC-RS Comments on FDA Draft IFU Guidance

August 28, 2019

Docket #: FDA-2019-D-1615

Principles of Premarket Pathways for Combination Products Guidance for Industry and FDA Staff

May 07, 2019

Docket #: FDA-2010-D-0078

IPAC-RS Comments on FDA ‘Principles of Premarket Pathways for Combination Products Guidance for Industry and FDA Staff’

May 7, 2019

Docket # FDA-2019-D-0078-0006

IPAC-RS Comments on FDA HF Guidance

November 29, 2018

Docket #: FDA-2018-D-3275

Comments to the docket on DRAFT MDI / DPI Guidance

June 20, 2018

Docket #: FDA-2018-D-1098

Draft Guidance on Comparative Analyses and Related Comparative Use Human Factors Studies

March 16, 2017

Docket #: FDA-2016-D-4412

IPAC-RS Comments to the USFDA prior to 2017 are available here.

USP

IPAC-RS Comments on USP <429> “Particle Size Analysis by Laser Light Diffraction” [PF 49(5)] (November 1, 2023)

IPAC-RS Comments on Pharmacopoeial Forum 49(2) Chapter <1031> "The Biocompatibility of Materials Used in Drug Containers, Medical Devices, and Implants" (May 2023)

IPAC-RS Comments on Pharmacopoeial Forum 49(2) Chapter <87> Biological Reactivity Tests, In Vitro and Chapter <88> Biological Reactivity Tests, In Vivo (May 2023)

IPAC-RS Comments on USP Revised Chapter <604> “Leak Rate (of aerosol containers)”  (January 2023)

IPAC-RS Comments on the USP Stimulus Article Testing the In Vitro Product Performance of Inhalation and Nasal Drug Products:  Views of the USP Expert Panel [PharmForum 48(5) September 2022] (November 29, 2022)

IPAC-RS Comments on USP <601> “Inhalation and Nasal Drug Products: Aerosols, Sprays, and Powders—Performance Quality Tests” PF48(4) (September 13, 2022)

IPAC-RS Comments on USP <1604> Presentation of Aerodynamic Particle Size Distribution (APSD) Measurement Data for Orally Inhaled Drug Products PF48(1) (March 31, 2022)

IPAC-RS Comments on Pharmacopoeial Forum Chapter <1031> The Biocompatibility of Materials Used in Drug Containers, Medical Devices, and Implants (September 30, 2021)
 

IPAC-RS Comments on Pharmacopoeial Forum Chapter <88> Biological Reactivity Tests, In Vivo (September 30, 2021)

IPAC-RS Comments on Pharmacopoeial Forum Chapter 〈87〉 Biological Reactivity Tests, In Vitro  (September 30, 2021)

IPAC-RS Response to the USP General Announcement “USP New Inhalation Product Monographs: Proposed Approach for Performance Tests Employing on-Standard Apparatus"

November 19, 2020

IPAC-RS Comments on USP <1220> Analytical Procedure Life Cycle

October 28, 2020

IPAC-RS Comments on USP's Approach for Future Revision of Biological Reactivity Chapters (87), (88), and (1031).

September 28, 2020

IPAC-RS Comments on USP White Paper "The Role of Public Standards in Assuring Quality of Digital Therapeutics"

August 17, 2020

 

IPAC-RS Comments on Elastomeric Components for Inhalation Packaging/Delivery Systems Jan 2020

IPAC-RS Comments on <601> Inhalation and Nasal Drug Products – Aerosols, Sprays, and Powders – Performance Quality Tests (Jan 2020)

IPAC-RS Comments on USP Stimulus Article

July 31, 2017

Docket #: Pharm.Forum 43(3) 2017]

Comments on “Proposed Revisions to the General Notices and Requirements” in Pharm.Forum 41(1)

March 17, 2015

Comments on USP 1661 Evaluation of Plastic Packaging Systems and Their Materials of Construction

January 29, 2015

Comments on USP chapters 661, 661.1, and 661.2

December 01, 2014

Comments on “USP Statistical Tools for Procedure Validation”

November 26, 2014

USP
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