Pink Sheet is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction

US FDA Focuses On Harmonization With The Launch Of Generic Drug Cluster

As Agency Calls For Scientific And Regulatory Alignment Globally

Executive Summary

To improve common standards for global development for generics and access to generics, FDA has launched the Generic Drug Cluster through the Global Generic Drug Affairs team established by the FDA’s Office of Generic Drugs. The agency has listed objectives through which it aims to increase scientific alignment among leading generic drug regulatory agencies. 

You may also be interested in...



FDA-EMA Pilot Could Further Push Global Generic Harmonization, But Will Sponsors Use It?

Regulators hope parallel scientific advice pilot for complex generics is more popular than brand program was at start; sponsors want use of foreign comparator products and tighter harmonization.

FDA-EMA Pilot Could Further Push Global Generic Harmonization, But Will Sponsors Use It?

Regulators hope parallel scientific advice pilot for complex generics is more popular than brand program was at start; sponsors want use of foreign comparator products and tighter harmonization.

Global development path proposed to ICH by FDA

Aset of “internationally harmonised guidelines on scientific and technical standards for generic drugs” should be developed through the International Council forHarmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH), according to a proposal that has been put forward by the US Food and Drug Administration (FDA).

Topics

UsernamePublicRestriction

Register

PS144509

Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel