People In Brief
This article was originally published in The Gray Sheet
Former NIH Director Bernadine P. Healy dies
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FDA 510(k) director joins Greenleaf: Heather Rosecrans Sept. 28 follows former CDRH Director Dan Schultz to the consulting firm Greenleaf Health, where she will serve as a senior regulatory advisor working with Greenleaf clients to advance innovative devices (1"The Gray Sheet" Sept. 20, 2010). Other former FDAers at Greenleaf include former deputy chief of staff Taryn Fritz Warpole and former FDA Commissioner Andrew von Eschenbach. Former FDA Chief of Staff Patrick Ronan founded the Washington, D.C., and Portola Valley, Calif., firm
Federal approaches to regulating pre-implantation genetic diagnosis (PGD) could entail creating a dedicated agency or giving an existing agency oversight of the procedure, a new report from the Genetics & Public Policy Center at Johns Hopkins University says
AMAG outlines plans for retrospective real-world evidence studies, and possibly a new placebo-controlled trial with a primary endpoint of preterm birth <32 weeks, in a filing opposing the Center for Drug Evaluation and Research’s proposal to withdraw the drug.