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 01 July 2015 | By Alexander Gaffney, RAC,
The US Food and Drug Administration (FDA) has released a pared-down list of diseases it plans to assess over the coming two years as part of its Patient-Focused Drug Development (PFDD) program—an integral part of the most recent authorization of the Prescription Drug User Fee Act (PDUFA).
The PFDD was created in an attempt to bring patients into the regulatory process in a more systematic way. Instead of asking for patient feedback on a drug-by-drug basis, the PFDD asks patients with a specific disease to describe the burden of their disease, their assessment of current treatment options, their ideal treatment and the risks they are willing to assume in return for more advanced treatment options.
The hope of regulators is that these preferences can then be incorporated into the regulatory review process. Companies, too, might stand to benefit by obtaining data from patients during the development process to support more lenient drug approval standards (i.e. desperate patients are more willing to assume some risk in return for the chance of treating symptoms of their disease).
For more, please read our Patient-Focused Drug Development Tracker
To date, FDA has held 15 patient-focused drug development meetings, with another planned for the end of 2015.
But those 16 diseases aren't the only ones set to receive attention from FDA. In October 2014, it also announced its intention to continue its PFDD program for several more years, focusing on a batch of potential new diseases and conditions.
At the time, FDA said it was considering 16 new conditions for possible inclusion in the PFDD program:
On 1 July 2015, FDA announced that just eight conditions will receive attention from FDA under its PFDD program between Fiscal Years 2016-2017:
Notably, two of these conditions—psoriasis and neuropathic pain associated with peripheral neuropathy—were not among FDA's initial list of potential disease candidates.
The selected group of diseases and conditions will bring FDA through the end of the current authorization period for PDUFA, which is set to expire in September 2017. FDA has previously said it is committed to holding at least 20 PFDD meetings, and is on pace to hold 24 meetings.
The current popularity of the programs all but ensures the PFDD program will continue into the next reauthorization of PDUFA, which is currently being negotiated.
FDA Federal Register Notice
Tags: PFDD, Patient-Focused Drug Development
Regulatory Focus newsletters
All the biggest regulatory news and happenings.