November 2010
National Council for the first time represented RAPS Annual Conference
China Pharmaceutical News, 10 November 2010
RAPS Annual Conference In Brief
The Tan Sheet (subscription required), 8 November 2010
Some CDRH Vacancies Proving Hard To Fill, Official Says
The Gray Sheet (subscription required), 8 November 2010
Regulatory News In Brief
The Gray Sheet (subscription required), 8 November 2010
FDA Drives Parallel Food Safety Reform Agenda As Legislation Chances Fade
The Gray Sheet (subscription required), 8 November 2010
Talks Resume On Recast Of Europe's Medical Device Directives
The Gray Sheet (subscription required), 8 November 2010
Process For Appealing FDA Actions To Be Clarified, CDRH Ombudsman Says
The Gray Sheet (subscription required), 1 November 2010
Experts See Changes to REMS With PDUFA Reauthorization
Washington Drug Letter (subscription required), 1 November 2010
US FDA Wants to Toughen Stance on Using Old Predicate Devices
International Medical Device Regulatory Monitor (subscription required), 1 November 2010
Midthun Named Permanent CBER Head, Biologics Safety Effort Launched
Washington Drug Letter (subscription required), 1 November 2010
Throckmorton: FDA Plans to Release PDUFA Proposal in Mid-2011
Washington Drug Letter (subscription required), 1 November 2010
CDRH Aiming to Toughen Stance On Use of Old Predicate Devices
Devices & Diagnostics Letter (subscription required), 1 November 2010
October 2010
Experts: REMS Process Likely to See Changes With PDUFA Reauthorization
Drug Industry Daily (subscription required), 29 October 2010
FDA Official Stresses "Flexibility" On Speeding Approval Of Drugs That Truly Stand Out
The Pink Sheet (subscription required), 28 October 2010
Downward FDA Approval Trend
ClinPage, 27 October 2010
Who’s Hiring Now? Check Out Regulatory Science
NIH OITE Careers Blog, 7 October 2010
Toe the line: Involve regulatory experts from the outset to avoid inadvertently overstepping the boundaries in social media strategy
Pharmaceutical Marketing Europe (PDF), September/October 2010
September 2010
CER, Reimbursement Issues Drawing More Attention From Reg Professionals
The Pink Sheet (subscription required), 20 September 2010
Survey highlights state of regulatory affairs profession
Science Careers Blog, 2 September 2010
August 2010
BioJobs: So You Think You Want to Be a Regulatory Affairs Professional?
BioJobBlog, 31 August 2010
Regulatory Affairs Professionals Taking on More Strategic Tasks: Survey
Drug Industry Daily (subscription required), 13 August 2010