May 26, 2019fda critical path

FDA, EMEA Milestone

Critical Path Win: New Biomarkers

July 10, 2008

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 and biotech) and government regulators (FDA, EMEA, and potentially others) to review and agree on new biomarkers for testing drug safety. (You can find a few more details in a ClinPage news brief.) Kidney Focus CPI, through its Predictive Safety Testing Consortium (PSTC), managed to get the two big regulating bodies to review biomarkers for drug-induced kidney injury in animals. Out of the 10 they saw, they liked seven. Woosley was psyched. “This is the first step toward global review of data,” he said. Perhaps even more remarkably, CPI has drug makers working together, too. “It’s also the first time 14…more...

CDASH Webinar Tomorrow

Carbonic e-Case Report Forms

February 13, 2008

The good news is: cloning works. The catch? You have to rethink your most cherished and convoluted case report forms (CRF). Barely two years ago, CDISC president Becky Kush, the well-travelled…more...

Surprise 2007 Approvals

FDA Births, OKs 2 Orphan Products

December 21, 2007

In a flurry of activity before the end of the year, the U.S. Food and Drug Administration approved two new drugs that—in a historic first for the embattled agency—had been developed…more...

Toward One FDA

At DIA, FDA Stresses Electronic Data

March 29, 2007

The recent Drug Information Association (DIA) conference on data management had the usual number of FDA presentations that put many commercial conferences to shame. And one of the most interesting FDA…more...

Fast-Track Status

Napo Proclaims Adaptive Design

March 20, 2007

ClinPage has drunk the Kool-Aid about adaptive designs. We think they could forever alter the timelines and budgets of entire portfolios of clinical trials. But there is hardly a technology we don’t like. Cable TV, perhaps. On the other hand, there is skepticism about adaptive trial designs. It boils down to three big factors. 1) Few companies…more...

ClinPage Exclusive: Jerry Schindler

The Biostatistical Case For EDC

January 26, 2007

It is utterly impossible to pigeonhole Dr. Jerald Schindler. We’ve tried. Schindler confounds the three easiest caricatures that any self-respecting journalist would reach for. Schindler is a biostatistician, but speaks fluidly, lucidly. He’s a vendor, but leaves his Cytel sales pitch in the overhead luggage bin on the plane to the meeting. President of the research division…more...

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