Regulatory Articles - Applied Clinical Trials

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Regulatory Articles

Safety Requirements Slow New Drug Approvals

November 1, 2009

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

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.

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.

Conducting Trials in Croatia

November 1, 2009

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

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.

Working Toward a Better Future

October 1, 2009

The EU struggles to get over its regulatory hurdles in an effort to further R&D success.

FDA Promotes Integrity and Compliance

October 1, 2009

Stiffer enforcement of research standards aims to restore the public's confidence in agency actions.

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.

Global Development Challenges Sponsors

September 1, 2009

International health crises expand testing of new vaccines and drug treatments for third-world diseases.

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