Welcome to our new website! If this is the first time you are logging in on the new site, you will need to reset your password. Please contact us at email@example.com if you need assistance.
The site navigation utilizes arrow, enter, escape, and space bar key commands. Left and right arrows move
across top level links and expand / close menus in sub levels. Up and Down arrows will open main level
menus and toggle through sub tier links. Enter and space open menus and escape closes them as well. Tab
will move on to the next part of the site rather than go through menu items.
The regulatory function is vital in making safe and effective healthcare products available worldwide. Individuals who ensure regulatory compliance and prepare submissions, as well as those whose main job function is clinical affairs or quality assurance are all considered regulatory professionals.
One of our most valuable contributions to the profession is the Regulatory Code of Ethics. The Code of Ethics provides regulatory professionals with core values that hold them to the highest standards of professional conduct.
Your membership opens the door to free learning resources on demand. Check out the Member Knowledge Center for free webcasts, publications and online courses.
Like all professions, regulatory is based on a shared set of competencies. The Regulatory Competency Framework describes the essential elements of what is required of regulatory professionals at four major career and professional levels.
Join the brightest minds in regulatory at the annual Regulatory Convergence. See the global regulatory community in action. Intensive workshops. Topical sessions. Meet ups with regulators. This is where it all comes together.
For 20 years, our flagship publication, Fundamentals of US Regulatory Affairs, has been giving regulatory professionals the insights and answers they need, right at their fingertips.
There are hundreds of RAC testing centers available worldwide. Any of the four RAC exams (US, EU, CAN or Global) may be taken at any location. Find an upcoming exam at a location near you.
Posted 27 February 2012 | By Alexander Gaffney, RAC
The US Food and Drug Administration (FDA) released on 27 February the text of their final decision on their withdrawal of Avastin's (bevacizumab) breast cancer indication.
FDA Commissioner Margaret Hamburg's 69-page decision is meant to be an explanation of FDA's application of the law and relevant regulations in its decision to withdraw approval for Avastin's breast cancer indication. Avastin is still marketed for several other indications.
The action followed a public hearing in June 2011 on the subject, as well as lengthy public debate on whether or not Avastin was safe and effective for treating breast cancer. The product's breast cancer indication was ultimately withdrawn on 18 November 2011.
Avastin, manufactured by Roche Holdings AG subsidiary Genentech, was originally granted its indication for breast cancer under an accelerated approval pathway for biological products (the 21 C.F.R §601.4 pathway). As part of a conditional accelerated approval, FDA ordered Genentech to conduct further studies to "verify and describe its clinical benefit."
Upon submission of those studies, FDA determined that it did not believe that Avastin was beneficial to patients with HER2-negative metastatic breast cancer (MBC), and proposed to withdraw its indication, which it did after the public hearing.
FDA - Proposal to Withdraw Approval for the Breast Cancer Indication for Avastin: Decision of the Commissioner
FDA - Final Decision on Withdrawal of Breast Cancer Indication for AVASTIN (Bevacizumab) Following Public Hearing; Availability
Tags: Text, HER2, Breast Cancer, Roche, Genentech, Avastin, Latest News, Hamburg, decision
Regulatory Focus newsletters
All the biggest regulatory news and happenings.