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.
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 03 September 2013
The pharmaceutical and biotech industry in the US is very heavily regulated under the Food, Drug and Cosmetic Act (and other laws). One specific area of intense scrutiny is the advertising and promotion of prescription drugs and biologics.
John Driscoll's new book, FDA Requirements for Prescription Drug Promotion, collects and organizes the most current information available to help anyone:
It is important for the reader to understand that due to the breadth of this field, it was not possible, in the space available, to dive too deeply in many pertinent and related topics (e.g., drug labeling, pharmacoeconomics, medical device promotion, and Department of Justice actions).
It is equally important that readers understand that the focus on just the Center for Drug Evaluation and Research promotional group (the Office of Prescription Drug Promotion) and drug regulations (21 CFR 202.1) does not mean that since biologics are not specifically called out, they are dealt with differently or that different rules apply. It is simply that the laws and regulations are the same and that the Center for Biologics Evaluation and Research promotional team (the Advertising and Promotional Labeling Branch) performs similar functions in similar ways, as they relate to biologics advertising and promotion since biologics are drugs.
FDA Requirements for Prescription Drug Promotion is a thorough compilation of current topics, historical references, FDA enforcement, etc., and provides a robust overview of applicable laws and regulations and should be used as an educational and reference tool by regulatory professionals, marketers and anyone who needs to understand the regulatory landscape around the advertising and promotion of drugs and biologics.
Editor's note: FDA Requirements for Prescription Drug Promotion is available from the RAPS Store both in print and as an e-book for $44.95 for RAPS members, or $54.95, plus shipping, for nonmembers.
Regulatory Focus newsletters
All the biggest regulatory news and happenings.