Tag Archives: CDER

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

No More Approvable Letters: An Expert's Take

By Walter Armstrong | Published: July 16, 2008
In response to last week’s blog about FDA’s announcement that, in future reviews of NDAs, it will ditch approvable and nonapprovable letters for “neutral” complete-review letters, Russ Somma sent an interesting and informative take on the likely effect of the new system on the industry. Somma is president of SommaTech, a pharmaceutical development technology consulting [...]
Posted in R&D, Regulatory, Safety | Also tagged , , , , , , | 1 Comment