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 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.
Download your copy of the new events calendar and see all the online workshops, conferences, RAC exams and European online workshops RAPS has planned for 2021 at a glance.
Registration is now open for RAPS Euro Convergence 2021! Attend to join peers from EU and around the world to gain insights and exchange ideas on the regions most pressing issues.
An invaluable resource for any professional engaged in designing, composing, compiling, or commenting on regulatory documentation
From self-assessments to help you identify your strengths and areas to focus on to reference books and online courses that will help you fill in the gaps in your regulatory knowledge, RAPS has the resources to help you prepare for the RAC exam.
Posted 08 August 2017 | By Zachary Brennan
The US Food and Drug Administration (FDA) is planning to release seven proposed rules and six final rules to close out 2017, according to an updated list of Department of Health and Human Services rulemakings.
Among the proposals coming are rulemakings dedicated to pediatric study plan requirements, internal decision making and supervisory review at FDA’s Center for Devices and Radiological Health, the withdrawal of a regulation that any drugs sterilized by irradiation would be considered a new drug, one on biologics license applications and master files and one on decreasing de novo classification burdens for device manufacturers.
Among the final rulemakings are those dedicated to updating FDA’s requirements for accepting clinical data used to bring new medical devices to market, to remove requirements to submit multiple paper copies of medical device regulatory pre-submissions and submissions and replace them with one copy in an electronic format, one to remove mandatory inspection requirements for biologics and replace them with a risk-based approach and one to allow an Institutional Review Board to waive informed consent under certain conditions for minimal risk clinical investigations.
Notably absent on the list for final rulemakings is one related to generic drug labels.
Scott Gottlieb, prior to being named FDA commissioner, told Focus in May 2016 on the proposed rule for generic labels: “FDA needs to bear more responsibility for updating the labels of old generic drugs and can take on that role, rather than foisting it onto generic drug makers in a way that will not only increase generic costs and expose them to the same sort of failure to warn suits that plague branded companies, but will undermine the generic model by creating incongruities between the labelling of the same generic drug, solely by virtue of the manufacturer and what CBE [changes-being-effected] supplements they happened to file. I think this is the most inefficient way to achieve what FDA purports to be their public health goal here, which is why I believe this was politically contrived, or at least politically influenced.”
Agency Rule List - Update 2017
Tags: FDA rulemakings, biologics manufacturing inspections, de novo, medical device rulemakings
Regulatory Focus newsletters
All the biggest regulatory news and happenings.