Protocol Design

The agency is shifting regulation of biotech therapies to its drug center, a streamlining initiative to be implemented by a new FDA commissioner.

Both personal health considerations and altruism helped keep this subject in a long-term study.

The EU?s progress in the battle against cancer measures how effective it is as research supporter instead of regulatory enforcer.

A review of Edyta J. Frackiewicz, Thomas M. Shiovitz, and Stanford S. Jhee's clinical trial book.

A new guideline details basic requirements for submitting a successful application for a proposed orphan drug in the European Union.

José Biller and Julien Bogousslavsky, Eds.

The EU?s Committee for Proprietary Medicinal Products describes the process clinical investigations should follow.

The EMEA updates its positions on placebos, Crohn?s disease trials, and postmarketing surveillance of drugs used by pregnant women.