History has been made. The FDA and the European Medicines Agency (EMEA) have reviewed biomarkers together and agreed. For the first time. Ever. That’s according to Raymond Woosley, president and CEO of the Critical Path Institute (CPI), an Arizona-based public-private partnership that’s trying to, among other things, get industry (pharma…more...

The Food and Drug Administration Amendment Act of 2007 (FDAAA) is vast. And overwhelming. At least one FDA official seems daunted by it, nine months after it became law. Take Sandra Kweder, deputy director of the FDA’s Office of New Drugs. Last month, at the 2008 Drug Information Association (DIA)…more...

We know you’re restless for more information about Form 3674, that beguiling new requirement that the FDA is imposing upon those sponsoring clinical trials. We were itching to know more ourselves. We rang the FDA. Unfortunately, after the phone call, we can’t say we know much more than before the…more...

Last week, we quoted Wyeth’s Joseph Camardo on the renewed user fee legislation known as FDAAA. He’s not sure the new post-marketing environment is starkly different from the old one. In thinking of the still-murky FDAAA regulatory landscape, we were reminded of a lyric from The Who: “Meet the new…more...

For the all the excitement and anticipation around adaptive designs for clinical trials, there’s always been one pesky fly in the ointment. Do regulators actually bless adaptive approaches when sponsors propose them? Has hype inflated expectations for such a promising technique? Adaptive trials—which include a statistical regimen to use the…more...

Paying lip service to the woes of the investigative site is a time-honored hobby in the world of clinical trials. Doing something to really help the site? Rare. Boston patient diary company PHT is trying to change that. It has revamped its electronic patient-reported outcome (ePRO) software to run on…more...

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...