FDA Gives Metabolism/Endocrinology Division An Acting Director
This article was originally published in The Pink Sheet Daily
Diabetes team leader Jean-Marc Guettier is detailed to replace Mary Parks as director of the Division of Metabolism and Endocrinology Products on a temporary basis as she moves up to Deputy Director of the Office of Drug Evaluation II.
You may also be interested in...
Key question at the Oct. 16 advisory committee review could be whether FDA should wait for results from an ongoing cardiovascular outcomes trial before significantly broadening the prescription fish oil product’s approval to include adults with high triglycerides and mixed dyslipidemia.
A re-adjudication of cardiovascular events in the RECORD trial reassured members of a June 5-6 advisory committee that the study findings are reliable, but did not erase uncertainties about CV risk associated with rosiglitazone.
Agency offers perspective in New England Journal of Medicine that lays out the case for careful use of drugs in a space with medical need but a long history of products with toxic side effects.