Regulatory - Applied Clinical Trials

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Regulatory

Safety Requirements Slow New Drug Approvals

November 1, 2009

FDA reviewers strive to assess new postmarketing programs while also evaluating applications.

Conducting Trials in Croatia

November 1, 2009

As a part of Europe, but not the European Union, trials in Croatia can encounter special challenges

Great Expectations: CROs Face Change in Italy

November 1, 2009

How Italy's new quality-driven regulations will ask more of CROs conducting activities in the country.

Health Issues Raise EU's Regulatory Profile

November 1, 2009

Health concerns require EU regulators to become more involved in the politics of health care.

Business and People Update

November 1, 2009

Industry news focusing on the people and organizations who work in the clinical trials profession

Schulman Associates IRB Establishes Itself in Canada

October 28, 2009

REMs: Battling the Unknowns

October 22, 2009

Why knowing a drug's risk and preparing for a risk evaluation mitigation strategy early on will considerably benefit a drug's development.

European Medicines Agency Implements Internal Reorganization

October 5, 2009

Keys to Drug Development in Latin America

October 1, 2009

The region and its regulatory agencies try to keep up with the rapidly growing clinical trials market.

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