Tag Archives: Janet Woodcock

CDER Addresses 'Challenges of Globalization' With a New Office

By Ben Comer | Published: June 8, 2011
In recognition of the difficulties presented by a rapidly expanding global drug market, FDA’s Center for Drug Evaluation and Research (CDER) has created a new office “dedicated to addressing the challenges of globalization and an increasingly complex drug supply chain,” according to memo sent by CDER director Janet Woodcock. The new “Office of Drug Security, Integrity [...]
Posted in FDA, Global, Regulatory, Safety, Supply Chain | Also tagged , | Leave a comment

Industry and FDA Brace for Change

By George Koroneos | Published: June 16, 2010
While the convention floor of the 46th annual meeting of the Drug Information Association bustled with the usual vendors touting the latest and greatest clinical trial technology, the panels (particularly those that featured FDA members) had a remarkably somber tone. The main refrain was: “Things are going to change and everyone must step up or get [...]
Posted in Regulatory, Strategy | Also tagged , , , , , | 1 Comment