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 email@example.com 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.
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.
With so many global regulation changes, staying informed is a challenge. Join other regulatory professionals as you navigate the gray 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.
Posted 19 April 2012 | By Alexander Gaffney, RAC
The US Food and Drug Administration (FDA) issued a safety communication on 19 April warning consumers about the risks associated with Other-Sonic Generic Ultrasound Transmission Gel after it found bacteria in the gel.
The safety communication came after the US Marshals Service raided the offices of the manufacturer, New Jersey-based Pharmaceutical Innovations, after the firm's product was connected with adverse events in 16 patients across the country.
CNN reports the gel is "used by medical professionals in ultrasounds, a procedure involving high-frequency sound waves to look at patients' organs."
FDA Associate Commissioner for Regulatory Affairs Dara Corrigan said in a statement the gel represented "serious health risks to patients, particularly vulnerable ones."
"FDA, with the assistance of our state partner, is taking aggressive enforcement action to protect the public health," added Corrigan.
FDA Safety Communication: Bacteria Found in Other-Sonic Generic Ultrasound Transmission Gel Poses Risk of Infection
CNN - U.S. marshals seize ultrasound gel that allegedly sickened 16 patients
Fierce Pharma Manufacturing - U.S. Marshals seize ultrasound gel containing dangerous levels of bacteria
Tags: Gel, Ultrasound, Sick, Raid, Marshals Service, bacteria, Adverse Events, Contamination, Latest News
Regulatory Focus newsletters
All the biggest regulatory news and happenings.