November 1, 2009
By:Jill Wechsler
FDA reviewers strive to assess new postmarketing programs while also evaluating applications.
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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:Philip Ward
The ICH GCP guideline continues to age and while members of the Institute of Clinical Research voice the need for its revision, industry debates whether changes are necessary.
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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: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 21, 2009
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August 21, 2009
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