Scrip 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

DELAYED: FDA Grapples With Generics Labeling Rule

This article was originally published in Scrip

Executive Summary

The FDA came under fire, but also got some praise, on Dec. 3 for again delaying a rule it initially had promised to finalize in December 2014 that would permit generic drug makers to independently revise their product labeling to add new safety updates before regulators review or approve such changes – just like brand-name manufacturers already do.

Advertisement
Advertisement
UsernamePublicRestriction

Register