FDA Wants Firms To Adopt Organization-Wide Quality Mentality
This article was originally published in The Gray Sheet
Executive Summary
FDA's device compliance office is encouraging manufacturers to make quality assurance an organization-wide concern rather than the responsibility of a discrete quality assurance unit.
You may also be interested in...
People In Brief
New CDRH compliance director: Steve Silverman is the new director of the FDA device center's Office of Compliance, agency staffers informed "The Gray Sheet" Sept. 10. Silverman, who has been a senior advisor in the compliance office for the past year, takes the helm from long-time Compliance Director Tim Ulatowski, who will retire from the agency Jan. 1, 2011 (1"The Gray Sheet" May 3, 2010). For the remainder of the year, Ulatowski will advise Silverman and lead special projects in the office. Prior to joining CDRH, Silverman was assistant director of the drug center's Office of Compliance. He has also worked in FDA's Office of Chief Counsel
Investors Go Berserk For Viking, Putting It Top Of Q1 Winners
The top 10 biggest share price winners and losers in Q1 from Evaluate show the investor frenzy for obesity drugs continues, while companies with governance doubts see shareholders retreat.
EU Consults On What Constitutes Personal & Commercially Confidential Data In Marketing Applications
Based on their experience with dealing with requests for access to documents over the past 12 years, EU regulators have proposed updating their guideline that provides for a harmonized approach to protecting personal data and business secrets in marketing authorization applications.