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IPAC-RS Comments on FDA EUA Draft Guidance 2020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Draft Guidance on Comparative Analyses and Related Comparative Use Human Factors Studies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

 
 

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