PRACS Institute closes; Chapter 7 imminent

Friday, March 22, 2013

By Suz Redfearn

At 4:30 p.m. central time on Wednesday, March 20, the approximately 480 employees at PRACS Institute’s Fargo, N.D., facility—one of the largest phase I units in the world with 544 beds—were told via conference call that PRACS was shutting its doors, effective immediately.

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Cetero reaches final resolution with FDA

Tuesday, April 24, 2012

Cary, N.C.-based CRO Cetero Research has reached a final resolution with the FDA over studies the company conducted in its Houston bioanalytical laboratory between April 1, 2005 and June 15, 2010. Following months of open collaboration between Cetero and the agency, the FDA summarized its final decision:

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Cetero Research expands senior management team

Tuesday, December 27, 2011

Cetero Research has reported two new appointments to its senior management team. Michael C. Fillios was named chief administrative officer, with leadership responsibility and oversight of human resources, information technology, project management, marketing and client services. David Coggin was named vice president, biometrics. He will oversee the operational management of PK/PD, data management, miostatistics and medical writing services.

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FDA: Generic transdermal patches should be tested in divergent climates

Monday, November 22, 2010

A patch that delivers medicine transdermally may act very differently on a resident of Fargo, N.D., than on someone in South Florida. Thus, the amount of medicine that enters their bloodstreams may be different. That’s the assertion of the FDA’s Office of Generic Drugs, and that’s why the regulatory body now asks that drug developers working on transdermal patches—at least in the generics realm—test their patches in multiple divergent climates.

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