Regulatory - Applied Clinical Trials

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.

Industry Squirms Under Antitrust Spotlight

August 1, 2008

Slowdown in new drugs to market prompts antitrust investigation by EU competition authorities.

Balancing the Three-Legged Stool

August 1, 2008

REMS are new only in name. The basic concept has long been central to drug regulation.

New Safety Surveillance System to Shape R&D

August 1, 2008

Broader access to health care data has potential to alter pre- and postmarketing clinical studies.

European Medicines Agency on the Move

July 1, 2008

From a new guidance on inspections to a bid to help the EU regain its R&D prowess, the Agency is busy.

Orphan Drug R&D Challenges Sponsors

July 1, 2008

Global harmonization, regulatory flexibility promise to expand treatments for rare and neglected diseases.

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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Abingdon Life Sciences, Inc. Enters Into Alliance With Stason Pharmaceuticals, Inc. to Provide Regulatory and Clinical Support

August Global News

DIA Adds More History to Boston

FDA Changes Wording for Drug Application Responses

ICREL Assesses EU Trials Directive

Better Feasibility for Global Clinical Trials

August 8, 2007

Clinical Trials in Russia 1

June 13, 2007

Clinical Trials in Russia 2

June 12, 2007

Costing Methods for Clinical Trials: A Comparison of Activity Based Costing and Traditional Costing