IPAC-RS COMMENTS

 
 
 

EMA

Guideline on the quality requirements for drug-device combinations

August 23, 2019

Docket #: CHMP/QWP/BWP/259165/2019

Orally Inhaled Product Bioequivalence Clinical Documentation Concept Paper

June 30, 2017

Docket #: EMA/CHMP/267194/2016

OINDP Quality Guideline Concept Paper

June 30, 2017

Docket #: EMA/CHMP/QWP/11577/2017

Drug-Device Combination Concept Paper

May 12, 2017

Docket #: EMA/CHMP/QWP/BWP/661488/2016

Revision of Points To Consider on the Requirements for Clinical Documentation for OIP

May 23, 2007

Docket #: CPMP/EWP/4151/00

Requirements for Pharmaceutical Documentation for Pressurised Metered Dose Inhalation Products

May 18, 2001

Docket #: CPMP/QWP/2845/00

 
 
 
 

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

 
 

US FOOD AND DRUG ADMINISTRATION (FDA)

 

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IPAC-RS Comments on FDA EUA Draft Guidance 2020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Draft Guidance on Comparative Analyses and Related Comparative Use Human Factors Studies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 <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