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 raps@raps.org if you need assistance.
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. Either RAC exam (Devices and Drugs) may be taken at any location. Find an upcoming exam at a location near you.
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.
Login to the RAPS is currently unavailable. We apologize for any inconvenience and are working to resolve the issue.
RAPS is closely monitoring developments in the Coronavirus (COVID-19) outbreak. See our public safety page for the latest updates.
Posted 26 September 2016 | By Zachary Brennan
The US Food and Drug Administration (FDA) is seeking comment from interested stakeholders to determine the utility of a list of examples of biomarkers used as outcomes in development of FDA-approved new molecular entities and new biological therapeutics.
The comments, which should be submitted by 18 November, may assist FDA in developing databases on biomarkers for drug development in the future, the agency said.
Biomarkers are frequently used in support of drug development, particularly as an outcome in a clinical trial.
FDA offers a look at biomarkers used in 12 therapeutic areas – including cardiology, oncology and infectious disease – that were accepted and used as outcomes in clinical trials as the basis for drug and biologic approvals from October 2007 to December 2015.
However, FDA notes that the appropriateness of the use of any particular biomarker as an outcome in one drug program should not be assumed to be appropriate for use in a different context or for a different drug development program. Therefore, drug sponsors are encouraged to consult with the relevant FDA review division as early as possible in drug development regarding the use of a particular biomarker in their planned clinical trials.
FDA is now soliciting suggestions and comments to determine the utility of the biomarker outcomes list and to identify any areas where more information can be disseminated on biomarkers that have been used to support the approval of drugs or biologics. Specifically, FDA wants to hear about:
Federal Register
Tags: biomarkers, biomarker examples, clinical trial biomarkers, FDA and biomarkers
Regulatory Focus newsletters
All the biggest regulatory news and happenings.