Managing conflicts of interest: A survival guide for biotechs

Article Abstract:

Federal law and other applicable rules are described to provide guidelines to overcome possible conflicts that might arise specifically from the relationships between life science companies and the clinicians they hire as investigators or participants in their trials. As with other legal and ethical issues confronting life science companies, it is critical for the company to understand the relevant law, gather relevant facts about the rules governing their particular situations and take necessary action.

Life sciences research

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FDA and EMEA pool scientific advice

Article Abstract:

The US Food and Drug Administration (FDA) and the European Medicines Agency (EMEA) on September 2004, announced a one-year pilot program that would start in January 2005 permitting companies to seek parallel scientific advice on testing their products from both the agencies simultaneously. The pilot program would allow the companies to discuss and get the input from both the agencies regarding various fundamental issues like trial duration and primary endpoints.

Europe, Product development, Biological products industry, Drug approval

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Cautious welcome for FDA pharmacogenomics guidance

Article Abstract:

The final version of the US Food and Drug Administration's (FDA) Guidance for Industry was issued by FDA on 22 March 2005 on the submission of pharmacogenomics data. Brain Spear, director of pharmacogenomics at Abbott Laboratories in Abott Park state that the document's main impact is on reassuring companies that are conducting early-stage pharmacogenomic experiments will not bring negative regulatory consequences.

Pharmacogenetics, Pharmacogenomics

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