FDA’s Drug Safety Office Reorganizing To Accommodate Influx Of PDUFA Staff
This article was originally published in The Tan Sheet
Executive Summary
FDA's Office of Surveillance and Epidemiology continues changing to strengthen its drug safety operations by reorganizing prior to increasing staff by 50 percent to undertake new regulatory authorities
You may also be interested in...
FDA’s 5-Year Plan For User Fees Gives Equal Footing To Post- And Pre-Market
Over the next five years, FDA will shift its regulatory focus to ensure that the safe and effective use of drugs is of equal importance as ushering safe and effective medicines to market
FDA’s “Dysfunctional” Hiring System May Be Good For Safety Databases
FDA's difficulty in hiring additional personnel has produced one upside for the agency: extra money that can be put into other operations
Pre-emption Limits Survive Congress, But Will Face Supreme Court
The FDA reauthorization law signed by President Bush Sept. 27 includes provisions intended to sustain limits on federal pre-emption, but the concept is challenged in several ongoing cases that could reach the Supreme Court in coming sessions