AER Electronic Filing Rule Sets Exemption Bar At Disaster Level
This article was originally published in The Tan Sheet
Executive Summary
FDA requires firms to submit post-market safety reports for drugs and biologics electronically beginning in June 2015. The agency says waivers will be allowed, but only will be temporary and rare, such as when disasters cut off electric power and Internet access.
You may also be interested in...
In Brief: Advertising Regulation, Vansen Consumer, Star Scientific
Supplement firms’ claims referred to FDA, FTC; review prompts new script for Zvelt ads; Vansen starts consumer portfolio with Canadian deal; Star Scientific pivots to drug development; and more In Brief.
Adverse Event Rule Would Require e-Conversion Of 20 Percent Of Submissions
FDA's proposed rule to require electronic submission of adverse event information would mandate a switch that industry already seems to be making rapidly
Mary Beth Clarke, CDER Exec Programs Office Director And Generic User Fee Shepherd, Will Retire
Clarke helped launch GDUFA I and negotiate GDUFA II, chaired the CDER Executive Committee and oversaw many other programs in the US FDA’s drugs center.