Regulatory - Applied Clinical Trials

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Regulatory Zone
News, developments and strategies for clinical trials conduct in relation to the FDA, EMEA and other global regulatory authorities overseeing the drug development industry.
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Real-World Clinical Testing Challenges
May 1, 2012
Expanding access to nonprescription drugs and facilitating comparative effectiveness research.
Ethics is all the Rage in Europe
May 1, 2012
Clinical trials should meet ethical and GCP standards no matter where in the world they are conducted.
Medical Device Trials
May 1, 2012
Understanding the United States' regulatory pathways and clinical operations.
Sunshine Act's Impact
April 1, 2012
The amendment addresses data concerns for both physicians and drug/device manufacturers.
Objective Internal Monitoring
April 1, 2012
Sponsors are responsible for monitoring studies, patient safety, and data integrity.

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Articles By Category
US
FDA-specific news, columns, and articles.
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EU
Latest news, columns, and articles about EMEA.
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Other Regions
Regulatory updates from worldwide regions
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New Agency to Soon Replace French AFSSAPS
Eric Abadie Resigns as Chair of the CHMP
High Court to Rule on Health Reform Legality
TAKE Solutions Partners with MENE Research to Capture Emerging Pharma Markets Globally
It's All Change at the Top for EMA
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