FDA

Multiple proposals for streamlining research emerge in legislation, expert reports.

Clinical trials should meet ethical and GCP standards no matter where in the world they are conducted.

Expanding access to nonprescription drugs and facilitating comparative effectiveness research.

Understanding the United States' regulatory pathways and clinical operations.

Demand for more information on study results and investigator payments create challenges.

The amendment addresses data concerns for both physicians and drug/device manufacturers.

The new Executive Director of the EMA has managed to stay calm under financial and political pressure.

Sponsors are responsible for monitoring studies, patient safety, and data integrity.

Congress, industry map out goals and concerns for revising FDA policies linked to user fee legislation.

Europe's struggling economies may have unexpected effects on the pharmaceutical sector.

FDA wants sponsors to build quality into protocols, adopt risk-based strategies to streamline trials.

A British Medical Journal survey suggests that misconduct in research is not going away.

Pressure to approve new user fees will affect policies for foreign studies and research methods.

While risk and uncertainty remain high, the pace of innovation will remain glacial.

The importance of safe use of imaging agents was highlighted at the Chicago Radiological Society of North America conference.

Patricia Brunko addresses the decline in European clinical trials, but still gives the industry hope.

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.

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

The Innovative Medicines Initative has launched several projects to improve quality of life.

Alternative approaches aim to tackle drug shortages, spur orphan drug development.

Multiple regulatory and reimbursement proposals are slated to expand legislation to renew PDUFA.

EU's new rules will be influenced by more than just those primarily responsible for pharmaceuticals.

Modernizing the Common Rule to update research policies could spell important changes.