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)

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Draft Guidance on Comparative Analyses and Related Comparative Use Human Factors Studies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