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.
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. Any of the four RAC exams (US, EU, CAN or Global) 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.
Posted 05 January 2018 | By Michael Mezher
In his second annual report as the director of the US Food Administration's (FDA) Center for Biologics Research and Evaluation(CBER), Peter Marks said the center continued to meet or exceed its performance goals in the final year of the last Prescription Drug User Fee Act (PDUFA V).
According to Marks, CBER exceeded its PDUFA goals by completing 100% of its FY2017 cohort of standard and priority biologics license application (BLA) and new drug application (NDA) reviews two months ahead of schedule.
The center also acted on all standard and priority efficacy supplements that were due in FY2017, and exceeded its target for reviewing 510(k) submissions by coming to a decision on all 510(k)s within 90 days.
Going beyond CBER's performance metrics, Marks says he is "particularly proud to have approved several therapeutic 'firsts'" in 2017.
Perhaps the most significant of which is the first US approval of a gene therapy, Novartis' chimeric antigen receptor T cell (CAR-T) therapy Kymriah (tisagenlecleucel) in August. The approval, which was dubbed an "historic action" by the agency was quickly followed by the approval of a second CAR-T therapy in October, Gilead's Yescarta (axicabtagene ciloleucel).
CBER also approved several other therapeutic firsts in FY2017, including MACI, an autologous cellularized scaffold for repairing knee cartilage; Odactra, the first allergen extract that can be taken sublingually; and Haegarda, the first subcutaneous C1 esterase inhibitor for preventing hereditary angioedema (HAE) attacks.
Marks further touted CBER's work on international public health issues in 2017, including completing seven expedited reviews for investigational new drug (IND) applications for Zika vaccines and providing assistance to other regulators on safety and efficacy concerns for investigational Ebola vaccines.
In addition, CBER issued or contributed to a number of significant guidance documents in FY2017, including guidances on demonstrating biosimilar interchangeability, statistical approaches to evaluate analytical similarity, deviation reporting for human cells, tissues and cellular and tissue-based products and guidance related to blood and tissue donor screening.
FDA
Tags: PDUFA, CBER, Kymriah
Regulatory Focus newsletters
All the biggest regulatory news and happenings.