Pink Sheet is part of the Business Intelligence Division 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

FDA Quality Metrics Proposal Sparks Objections, Disarray

This article was originally published in The Gold Sheet

Executive Summary

Pharmaceutical manufacturers argued FDA can’t make them report quality metrics data, but there was little else they could agree on in their initial reaction to the complex, enforceable reporting scheme FDA has proposed in its draft quality metrics guidance.


Related Content

FDA Urges Full Participation In Quality Metrics Program
FDA’s Revised Quality Metrics Program: Voluntary Now, Mandatory Later
FDA Outlines Plans to Use Quality Metrics for Surveillance of Manufacturers