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

US FDA Collates GMP Data Integrity Advice Into New Guidance

This article was originally published in SRA

Executive Summary

Some questions and answers about data integrity that the US Food and Drug Administration published April 14 as draft guidance could go a long way toward helping drug manufacturers avoid the type of import alerts and warning letters that in recent years have come to dominate the agency's drug good manufacturing practices enforcement activities1,2.

Advertisement
Advertisement
UsernamePublicRestriction

Register