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 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.
Share your knowledge and expertise with your regulatory peers by submitting an in-depth, evidence-based article focusing on key areas and emerging issues in the global regulatory landscape.
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.
Registration is now open for RAPS Convergence 2021! Gather with the regulatory community 12-15 September for four days of learning, engagement, and excitement.
Keep the sparks coming! Delegates of the conference have access to on-demand content until the end of October 2021.
This updated edition is a great reference for anyone working in multinational product development and marketing.
Regipedia is an interactive resource created to benefit RAPS members with 24/7 access to more than 2,300 regulatory terms.
Hear from leaders around the globe as they share insights about their experiences and lessons learned throughout their certification journey.
Posted 12 September 2014 | By Alexander Gaffney, RAC,
The US Food and Drug Administration (FDA) has received approval to go forward with a proposed study to study the effects of "distractions" in direct-to-consumer drug advertising, which it hypothesizes may reduce consumers' ability to remember risk information about a product.
FDA announced the proposed study in May 2014, saying that while "previous research has shown that factors such as multiple scene changes and music in advertising can be distracting," that research was limited. "The effects of distraction during the major statement of risks on consumers' perceptions and risk recall have not been tested in the presence of risk-reinforcing superimposed text," FDA said in its Federal Register notice calling for comments on the proposed study.
FDA's proposed study would look at how "potentially distracting images and sounds" might affect risk recall, regulators said.
To assess this, FDA says it plans to conduct an eye-tracking study "to determine how superimposed risk information and the MedWatch statement are perceived in DTC ads and also the impact of distraction," allowing regulators to determine if a participant is actually paying attention to the intended information.
"We hypothesize that distracting audio and visuals during the major statement will decrease risk recall, risk perceptions, and attention to superimposed text risk information," FDA explained.
The two-phase study will involve a 30-participant pilot, followed by a 300-participant main study. Participants will be those who self-identify as wanting to lose more than 30 pounds who are at least 18 years of age. The study will focus on a fictitious prescription weight loss drug, and split patients into two groups: one with "low" levels of distractions, and another with "high" levels of distraction. FDA said these advertisements have already been developed and pre-tested.
Now FDA's proposed study has been given the final go-ahead by the Office of Management and Budget (OMB), the federal office in charge of approving all information collections. The approval, announced on 11 September 2014 by FDA in the Federal Register, will allow the agency to proceed with the study as proposed and without change.
The study questionnaires may be found here, while all other information about the study can be found here.
FDA Announcement
Tags: DTC Advertising, Direct-to-Consumer Drug Advertising, Pharmaceutical Advertising, Distractions in Drug Advertisements
Regulatory Focus newsletters
All the biggest regulatory news and happenings.