FDA Renewing Push For Consistency In CDER/CBER Oncology Reviews
Executive Summary
FDA is trying to improve communications and consistency in oncologic product reviews conducted by the drugs and biologics centers
You may also be interested in...
Cancer Clinical Trial Sponsors Increasingly Favor Non-U.S. Sites, FDA Finds
The number of clinical trials used for registration of anticancer agents performed at least partially outside the U.S. has increased by approximately 50% in the last five years, FDA reported at the American Society of Clinical Oncology annual meeting
Cancer Clinical Trial Sponsors Increasingly Favor Non-U.S. Sites, FDA Finds
The number of clinical trials used for registration of anticancer agents performed at least partially outside the U.S. has increased by approximately 50% in the last five years, FDA reported at the American Society of Clinical Oncology annual meeting
FDA Oncology Reviews Need Common “Best Practices” – Erbitux Follow-Up
FDA's drug and biologic centers should institute common "best practices" for oncology reviews, the Energy & Commerce Committee told the agency in a June 27 follow-up to the Erbitux hearing