Links
Digital Productivity
- Merlin Mann
- Mann's "Inbox Zero" Video
- Black Belt Productivity
- Matthew Cornell
- Lifehacker.com
- Lifehack.org
- David Seah
- Ruthless Email
- Mike St. Pierre
Organizations
Conferences
Info & Opinion
May 12, 2008
Nudging By FDA
FDA-Ready Graphs From Insightful
Inspired by Web 2.0 tools that foster sharing and collaboration, Insightful Software released new software to generate charts and graphs in a regulated setting.
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.
Guidance On Schedule
FDA’s Wilson On Adaptive Paths
A prominent official talks about how to approach the regulatory aspects of adaptive designs.
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.
‘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.
In a session about two of the most promising pharmaceutical markets (for both sales and clinical trials) the 2007 Regulatory Affairs Professionals Society conference had well-travelled speakers to a variety of countries. We happened to hear two presentations that were designed to spare the audience the pain of easy mistakes… more...
At the annual conference of the Regulatory Affairs Professionals Society (RAPS), held in Boston last week, the FDA’s Sandra Kweder (deputy director of the Office of New Drugs in CDER) gave a well-attended talk packed with sugary rhetoric. Such statements could be taken as indicating that nothing will change in… more...
Sitting there at the 2007 Regulatory Affairs Professional Society (RAPS) conference in Boston, we had a premonition. It turned out to be Bob Dylan, circa 1965: “Something is happening here but you don’t know what it is.” We couldn’t tell if Sandra Kweder was trying to relieve some of the… more...
The Regulatory Affairs Professionals Society (RAPS) is gearing up for its annual meeting, later this month in Boston. One of the sessions at the conference is about the mandatory transition to the electronic common technical document (eCTD). Early next year, the FDA will accept only two types of regulatory submissions:… more...
The Clinical Data Interchange Standards Consortium (CDISC) does not want for savvy high-energy volunteers or high-profile member organizations. For evidence of that, just hang out at CDISC’s user meeting, which is coming up in October. There’s just one problem. Using CDISC data standards, and doing so consistently throughout an organization,… more...
We’re digesting our DIA notes from this year’s annual meeting in Atlanta. Still. One of memorable presentations was from Susan Flynn, chief quality officer at Clinsys Clinical Research, a contract research organization. The company has 300 clinical research professionals; its headquarters are in New Jersey. Flynn speaks with the benefit… more...
Does Microsoft matter in clinical trials? Is it staring numbly at the start of an era of enterprise-worthy, web-based tools from Google? Or does Microsoft have unique hardware, application and networking tools that make it a more or less indispensable part of the technological infrastructure of the modern clinical trial?… more...
Despite the fact that some European biotechs have been touting microdosing as the next big thing, sponsors in the U.S. are still not rushing out in great numbers to give the extremely low-dose trials a whirl. In fact, says the FDA‘s David Jacobson-Kram, associate director of pharmacology and toxicology in… more...
Mission3, an Arizona-based provider of pharmaceutical project, document, and submission management software, announced that it continues its drive for good informatics practices through its partnership with LSIT Global Institute. LSIT has published an article by Dirk Karsten Beth, president of Mission3. Writes Beth: “The eCTD submission [electronic common technical document]… more...
Does the digital world have warts? Yes. They’re called PDFs. The venerable Adobe format is a digital scourge. The PDF is not truly searchable. It’s not version controlled. It’s not auditable. PDFs are big, dumb, proliferating images. There is only one safe, FDA-approved treatment for PDFs: XML. XML also treats… more...
