Applied Clinical Trials-05-01-2002

Readers respond to articles and editorials.

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

Federal prosecutors target sponsors and clinical investigators who misuse federal funds or violate research requirements while FDA proposes new policies and Congress eyes reforms.

Improving adverse event reporting can lead to improved safety profiles and, consequently, fewer drugs pulled from the market.

Family man, educator, mentor, athlete--and a man on a quest with Amgen Inc for new and better oncology treatments.

A new method, based on hard-earned experience, can help you reduce the risk of protocol inconsistencies and ambiguities during the protocol development process.