FDA Employs Carrot, Stick Under Unapproved Drug Enforcement Strategy
This article was originally published in The Tan Sheet
Executive Summary
Unapproved drugs that "present direct challenges" to FDA's new drug approval and OTC drug monograph systems will be high priority for enforcement actions, according to an agency guidance released June 8
You may also be interested in...
CDER Enforcement Priorities Include Quality Control, Drug "Criminalization"
FDA's Center for Drug Evaluation and Research will crack down on manufacturers that attempt to "farm out responsibility," firms that fail to meet reporting requirements and the general "criminalization of our drug supply," said Deb Autor, director of the center's compliance office
CDER Enforcement Priorities Include Quality Control, Drug "Criminalization"
FDA's Center for Drug Evaluation and Research will crack down on manufacturers that attempt to "farm out responsibility," firms that fail to meet reporting requirements and the general "criminalization of our drug supply," said Deb Autor, director of the center's compliance office
CDER Enforcement Priorities Include Quality Control, Drug "Criminalization"
FDA's Center for Drug Evaluation and Research will crack down on manufacturers that attempt to "farm out responsibility," firms that fail to meet reporting requirements and the general "criminalization of our drug supply," said Deb Autor, director of the center's compliance office