FDA

EMEA responds to more medicines, increase in complex procedures, and plethora of committees.

Globalization and reform initiatives will take part in shaping biomedical research and clinical studies.

A comprehensive listing of U.S. departments and offices that includes the telephone numbers of directors, commissioners, and advisors.

The latest version of the glossary, providing hundreds of definitions for key terminology related to clinical research.

Find out the latest on industry organizations and what they offer as membership benefits.

A listing of organizations, colleges, and universities that offer courses specific to advancing the education of clinical research professionals.

The management board has a supervisory role with general responsibility for budgetary and planning matters, the appointment of the Executive Director, and the monitoring of the Agency's performance.

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

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

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

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

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

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

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

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

The globalization of clinical research leads both sides of the Atlantic to collaborate on GCP inspections.

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

Guidance for the design and conduct of international bioequivalence trials.

Taking advantage of the eCTD's cross-application feature, linking from NDA back to IND.

Pressure to reduce health care spending puts R&D, costs, and coverage on the negotiating table.

Contradicting decisions call for a unified clinical trial authorization process.