Silo vs. Life Cycle
Octagon’s End-To-End Vision
The software company is rethinking the way data is collected with the regulatory process in mind. more...
May 21, 2012Regulatory
FDA Needs IT
Throckmorton at RAPS Meeting
With a new emphasis on databases and systems, FDA and its CDER branch prepare for a post-Vioxx landscape. more...
100 Languages Spoken Here
Profile: Global Language Solutions
With ISO certification, a California firm tries to lower regulatory risks inherent in translation by ensuring high quality—and avoiding mistakes. more...
Coast: Ethics & Efficiency
Inc. List’s Only IRB
Coast IRB just made Inc. magazine’s list of America’s 5,000 fastest-growing private companies. It’s the only IRB ever to do so. more...
Rejecting Schering's Sugammadex
Pre-Election FDA On Lockdown
Mark Mansour of the Bryan Cave law firm says the FDA is on hold while America selects a president. more...
FDA, EMEA Milestone
Critical Path Win: New Biomarkers
Arizona’s Critical Path Institute gets industry, FDA and EMEA to agree on seven renal biomarkers. more...
Stopping Traffic
Coast IRB’s DIA Psychic
Close encounters on the 2008 DIA exhibit floor. Plus Nintendo Wiis, flat-screen TVs, stuffed animals and Russian dolls. more...
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...
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...
