New FDAAA Paperwork
New FDA Form 3674, Explained
The FDA’s new Form 3674 is an attestation that a trial has been registered in clinicaltrials.gov. more...
February 8, 2012Regulatory
REMS Risks
FDA’s Woodcock On FDAAA
At Outcome’s Post-Approval Summit at Harvard, CDER head Janet Woodcock walked the audience through what FDAAA means. more...
Webinar: Tessella, United Biosource
Adaptive Designs: The Regulatory Issues
Two leading firms, Tessella and United Biosource, discuss the perception that regulators are trying to slow down the adoption of adaptive designs. more...
Profile: Phlexglobal
Mastering The Trial Master File
More global locations and outsourcing can make for a messy process to generate a trial master file (TMF). Phlexglobal bundles services and software to help. more...
Sponsors in denial?
2008 eCTD Train Wreck?
Warren Perry of Qumas warns that some of the industry will be unprepared for the FDA insisting on its long-planned transition to the eCTD. more...
Report Blames FDA
GAO: Elderly Trial Data Lacking
The GAO says the FDA and sponsors aren’t doing enough to analyze clinical trial data about the elderly. more...
Guidance On Schedule
FDA’s Wilson On Adaptive Paths
A prominent official talks about how to approach the regulatory aspects of adaptive designs. more...
Strategies from Pfizer & Pacific Bridge
RAPS 2007: Going To India & China
At the recent annual meeting for regulatory affairs professionals, there were two presentations on the right attitude for China and Brazil. more...
‘Enough--This Is The Label’
RAPS: CDER’s Kweder, Part II
Reading between the lines of a presentation by Sandra Kweder of FDA-CDER. How industry may have to adapt to an evolving review process at the agency. more...
New FDA Review Process
RAPS: Kweder of CDER, Part I
The FDA’s Sandra Kweder talks about Vioxx, a consultant’s study of its process, and how that process is about to be standardized across all sections of CDER. A report from the 2007 RAPS conference for regulatory affairs pros. more...
eCTD Readiness
Forward-Looking Regulatory Solutions
There is growing interest in software to generate the electronic common technical document (eCTD). more...
When Speed Means Slow
Rozwell on Data Standards (Podcast #1)
Gartner distinguished analyst Carol Rozwell talks about drug safety, contract research organizations, data mining and other topics related to CDISC standards. more...
Searching For Sticky Notes
Auditing Technology At Trial Sites
What one auditor of technology at clinical sites looks for. more...
Clinical Content Management
FCG Partners with Microsoft
Since most people in the industry use Office to create clinical trial documents, Microsoft and FCG say it’s high time there is a secure environment for managing it in a regulated industry. The appeal of MOSS. more...
Low Interest So Far
Microdosing Update From FDA
Yes, microdosing is part of the FDA’s Critical Path Initiative. But no, sponsors don’t seem to be interested in extremely low-dose trials yet. Why? The FDA’s David Jacobson-Kram offers some thoughts. more...
Bio-Optronics, Trialstat, Woodcock in NYT
News Briefs
News for June 4th. more...
