October 22, 2009 By:Marissa Shapiro
Why knowing a drug's risk and preparing for a risk evaluation mitigation strategy early on will considerably benefit a drug's development.
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October 1, 2009 By:Peter O'Donnell
The EU struggles to get over its regulatory hurdles in an effort to further R&D success.
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October 1, 2009 By:Juliane Carvalho, Ekopimo Ibia
The region and its regulatory agencies try to keep up with the rapidly growing clinical trials market.
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October 1, 2009 By:Jill Wechsler
Stiffer enforcement of research standards aims to restore the public's confidence in agency actions.
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September 1, 2009 By:Peter O'Donnell
The globalization of clinical research leads both sides of the Atlantic to collaborate on GCP inspections.
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September 1, 2009 By:Lisa Henderson
Abuse and misuse of extended-relief opioids, get regulatory attention and potential guidance from Onsolis' REMS.
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September 1, 2009 By:Jill Wechsler
International health crises expand testing of new vaccines and drug treatments for third-world diseases.
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August 20, 2009 By:Michelle Perez
Taking advantage of the eCTD's cross-application feature, linking from NDA back to IND.
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