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 21 February 2018 | By Zachary Brennan
For the second time in the last month, the District of Columbia's District Court took the US Food and Drug Administration's (FDA) side in the agency's decision to deny a six-month extension of market exclusivity for Amgen's blockbuster Sensipar (cinacalcet).
In the earlier opinion and order, the court granted FDA summary judgment on all but one of Amgen's claims: that the agency's denial of pediatric exclusivity for Sensipar was inconsistent with its decision to grant pediatric exclusivity for Johnson & Johnson's drug Ortho Tri-Cyclen.
The court had asked FDA to explain its prior decision to grant pediatric exclusivity for Ortho Tri-Cyclen and why it was consistent with its decision denying pediatric exclusivity for Sensipar.
And since that decision, FDA added new documents and explained how it applied the same standard to Sensipar and Ortho Tri-Cyclen.
The court "is now satisfied that the FDA has offered a reasoned—and reasonable—basis for distinguishing the Ortho Tri-Cyclen precedent," the decision from 17 February said.
Yale University's Collaboration for Research Integrity and Transparency fellow Jeanie Kim and faculty co-directors Amy Kapczynski and Joseph Ross wrote: "By ruling for the FDA, the judge preserved the agency's authority and discretion to make pediatric exclusivity determinations in a way that encourages clinically meaningful research."
In terms of when Sensipar generics may come to market, Bernstein biotech analyst Ronny Gal said in an investor note sent Wednesday that on 8 March, unless ordered otherwise by the courts, FDA will convert pending abbreviated new drug applications (ANDAs) to final approvals and Sensipar generics will be legally allowed to launch at risk.
However, he also noted that Amgen recently listed a formulation patent that will not expire until 2026 and the company sued the generic filers in December 2017.
Decision
Regulatory Focus newsletters
All the biggest regulatory news and happenings.