Agency Activity

US FDA signs agreement with university

The US Food and Drug Administration and the University of Pennsylvania are to collaborate in an effort to advance the scientific basis for the regulatory approval process and medical product development¹.

A memorandum of understanding signed by the two institutions focuses on the areas of translational therapeutics, diagnostics, bioinformatics, the development of new clinical trial models, drug-device co-development and innovative drug therapy monitoring programmes.

The five-year agreement, which will involve the exchange of students and experts, is aimed at improving the quality and quantity of professionals in the field of translational medicine and therapeutics. The FDA expects to realise some specific goals through the collaboration, which became effective on 24 July. The goals include advancing the:

• use of new technological tools to speed up development of safer, more useful drugs, biologics and medical devices targeted at individuals rather than at populations;
• use of pharmacoepidemiology to monitor the efficacy, safety and cost-effectiveness of drugs and devices after they are marketed;
• understanding of co-development processes for companion drug diagnostics for targeted therapies; and
• entry of new medical products into the marketplace at reduced cost without compromising safety or efficacy.

References

1. Federal Register, 9 September 2008, 73(175), 52385-52392, http://edocket.access.gpo.gov/2008/pdf/E8-20932.pdf