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.
With so many global regulation changes, staying informed is a challenge. Join other regulatory professionals as you navigate the gray 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 March 2012 | By
The Supreme Court of the United States (SCOTUS) ruled Monday (26 March) to send a case by Myriad Genetics Inc. back to a lower court for review in light of its recent decision, Mayo Collaborative Services v. Prometheus Laboratories, in which the court decided Prometheus's patents on methods to determine the proper dosing for a disease were invalid.
In Association for Molecular pathology v. Myriad Genetics, SCOTUS was to consider whether patents held by Myriad on the breast cancer genes BRCA1 and BRCA2 were valid under the law. Its ruling in Prometheus was predicated on the notion that scientifically observable natural phenomena are not patentable, reports Reuters.
Monday's ruling sends the case back to the US Court of Appeals for the Federal Circuit for further review, which may ultimately delay SCOTUS from ruling on it for several more years.
Reuters - Myriad gene patent ruling sent back to lower court
Genetic Engineering & Biotechnology News - Lawyers Offer Predictions for Myriad, Diagnostic Field Based on Supreme Court's Decision Against Prometheus
The Boston Herald - Supreme Court throws out human gene patents
Regulatory Focus - Nestle Loses Patent Case That Could Have Stifled IVD Development
Tags: BRCA, Myriad, Mayo, Prometheus, Breast Cancer, SCOTUS, Law, Latest News, Patent, Supreme Court
Regulatory Focus newsletters
All the biggest regulatory news and happenings.