Food and Drug Administration Initiative

The FDA initiative is designed to work collaboratively with multiple stakeholders from government, industry, academia, and NGOs to promote more efficient and consistent processes at the FDA for the handling of oncology products.  These efforts contributed to the creation of new Office of Oncology Products at FDA, which was announced on July 16^th of 2004 by HHS Secretary Tommy Thompson.  The purpose of this new office is to consolidate into a single administrative entity the authority over an array of biologics, drugs and imaging technologies with cancer indications.  Such expanded and centralized jurisdiction is intended to streamline the review process so that safer and more effective drugs can get to patients sooner.  As a subset of the office, the FDA plans to create an “Oncology Program” designed to better coordinate and integrate cancer-related activities throughout the agency such as regulatory policy and cross-agency consultations