Pink Sheet is part of Pharma Intelligence UK Limited

This site is operated by Pharma Intelligence UK Limited, a company registered in England and Wales with company number 13787459 whose registered office is 5 Howick Place, London SW1P 1WG. The Pharma Intelligence group is owned by Caerus Topco S.à r.l. and all copyright resides with the group.

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

FDA’s OPQ Chief Tells Generic Drug Makers Its Time To Up Their Quality Game

Executive Summary

The head of US FDA’s drug quality office comments on quality-related topics at the GRx-Biosims meeting; sheds more light on facility rating system plan.

You may also be interested in...



The FDA Builds On Lessons Learned In Rebuilding Quality Metrics Program

US FDA officials tell industry that implementing a quality metrics program is an agency priority and that a rejiggered program will incorporate various elements of other quality metrics initiatives being piloted by the agency, industry and academia.

Drug Review Reorganization At US FDA Coming Into Focus

Oncology, neuroscience, and infectious diseases get acting directors as the expansion and renovation of the Office of New Drugs moves into Phase II.

Drug Shortage Plan Would Grade Firms To Encourage High-Quality Production

US FDA task force recommends a rating system that purchasers could rely on to reward manufacturers with robust management systems.

Related Content

Topics

Latest Headlines
See All
UsernamePublicRestriction

Register

PS141152

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