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.
Resources, news and special offers to support you and your professional development during this difficult time.
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.
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.
Posted 06 July 2017 | By Zachary Brennan
Endo International announced Thursday that it will comply with the US Food and Drug Administration’s (FDA) request to remove its opioid Opana ER (oxymorphone hydrochloride extended release) from the US market.
FDA made the request 9 June “based on its concern that the benefits of the drug may no longer outweigh its risks” after "a significant shift in the route of abuse of Opana ER from nasal to injection following the product’s reformulation.”
As a result, the Dublin-based company said it expects to incur a pre-tax impairment charge of approximately $20 million in the second quarter of 2017. Net sales of Opana ER in 2016 were $158.9 million.
FDA Commissioner Scott Gottlieb and CDER Director Janet Woodcock on Thursday wrote in a JAMA viewpoint that the agency “can do more to confront” the opioid crisis.
While describing the agency’s look into the illicit use of Opana ER, Gottlieb and Woodcock note that the agency has commissioned a study from the National Academies of Sciences, Engineering, and
Medicine to identify additional actions the agency should consider to address the opioid crisis, “with a particular focus on approaches the agency can take to improve its benefit-risk framework for opioids to support a more formal assessment of the public health risks and benefits.”
FDA has also recently pledged to take a closer look at the data supporting abuse-deterrent labeling for opioids.
The decision to pull Opana ER from the US market also comes as the Center for Lawful Access and Abuse Deterrence on 3 July petitioned FDA to require companies that do not have abuse-deterrent opioids to convert products to such formulations within three years or have their products removed from the market.
“Our current petition provides manufacturers of non-abuse-deterrent opioids with three years from the date of this Citizen petition or the date of a third ADO approval, to remove their product and replace it with an ADO, leaving adequate time for transition,” the petition says.
Tags: Endo, Opana ER, opioids, opioid crisis
Regulatory Focus newsletters
All the biggest regulatory news and happenings.