FDA

Standard operating procedures need to be in place for the handling of suspected research misconduct.

Investigator training should not be a "one-off" session at the start of clinical trial.

Healthcare is seen as one of the most promising sectors to help boost EU employment.

Will ethics committees buy into the radical new approach of latest draft regulation?

A framework is needed to facilitate, promote, and reward basic and applied research for adults and children.

An analysis of warning letters and the findings reported from 1996 to 2010.

The European Union is preparing a report on the lessons learned from its 2006 pediatric regulation.

An entire section of Horizon 2020 is devoted to health, demographic change, and well-being.

Proposed rule changes on public information in Europe never make it to fruition.

Biosimilars are a steadily growing new field of biopharmaceutical development and clinical research.

European Parliament voted against clearing the agency's accounts because of management concerns.

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.

European Forum for Good Clinical Practice meeting on informed consent draws a huge crowd.

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