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August 22, 2008
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.
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.
Tech Preview: Clinical Tablet
PHT Device Aimed At Sites
The patient-reported outcome company moves its software to a Samsung device with a new form factor and operating system.
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.
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.
From hundreds to thousands of pages, the trial master file (TMF) contains every last bit of data associated with a trial including, under Good Clinical Practice (GCP), the signatures of all the investigators. Many key pieces of the electronic common technical document (eCTD) are drawn from the TMF. Surprisingly, there… more...
It’s been coming for a long time. Now it’s here. The FDA and the pharmaceutical industry adopt new processes imperceptibly. Deliberately. But as the new year begins, 2008 has at least one stark shift. As of now, electronic regulatory submissions to the U.S. authorities must use the electronic common technical… more...
How fast can your company analyze its clinical data? If a medical journal says your data are incomplete on a Thursday morning, is the turnaround time for your response a) one month b) six months or c) “it depends”? In an era of withering scrutiny of clinical research, biostatisticians are… more...
Data about the elderly aren’t properly represented in clinical studies, and the aged may be at risk when they take prescription drugs. That was the upshot of Prescription Drugs: FDA Guidance and Regulations Related to Data on Elderly Persons in Clinical Drug Trials, a recent report by the Government Accountability… more...
Adaptive trials are very much on the minds of the clinical trial community, with a few big sponsors like Novartis and Merck plunging into the systems necessary to support them. Many other companies are wondering about just how much infrastructure (technologically) or process change (organizationally) will be necessary to implement… more...
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...
