Monograph OTCs Subject To Adverse Event Reporting Under Hatch Bill
This article was originally published in The Rose Sheet
Executive Summary
Firms that make, pack or distribute over-the-counter drugs approved under monographs will have to be in compliance with a new adverse event reporting law by December 2007 if President George W. Bush signs a recently passed bill
You may also be interested in...
Expert Gives Lowdown On Adverse Event Reporting Bill For Monograph OTCs
The compliance of companies newly subject to adverse event reporting and record-keeping requirements will likely be evaluated by FDA on a "performance-oriented basis," said Rick Kingston, PharmD, president and senior clinical toxicologist at SafetyCall International, an adverse event call center
Judge Orders FDA, Food Safety Group To Set FSMA Implementation Date
FDA’s delays in implementing the Food Safety Modernization Act violated FSMA and the Administrative Procedures Act, a federal court finds in an April 22 order. The agency must meet with plaintiff Center for Food Safety to agree on new implementation deadlines by May 20.