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 December 2014 | By Alexander Gaffney, RAC,
A new draft guidance document issued by the US Food and Drug Administration (FDA) calls for all over-the-counter (OTC) drugs containing acetaminophen to be labeled with a new statement warning consumers about the risk of the products causing serious skin reactions.
The new guidance, Recommended Warning for Over-the-Counter Acetaminophen-Containing Drug Products and Labeling Statements Regarding Serious Skin Reactions, follows a 2013 warning by FDA that the drugs are associated with a risk of developing serious skin reactions.
Those reactions, including Stevens-Johnson Syndrome (SJS), toxic epidermal necrolysis (TEN), and acute generalized exanthematous pustulosis (AGEP), are known to be fatal and can occur after just a single use.
While FDA said it was difficult to determine the exact frequency with which the side effects occurred, regulators said that they believed the events occurred "rarely."
FDA's new draft recommendations are intended to warn consumers and healthcare providers about those risks, and apply to all single- and combination-ingredient acetaminophen-containing products marketed under the Tentative Final Monograph (TFM) for Internal Analgesic, Antipyretic, and Antirheumatic (IAAA) Drug Products for Over-the-Counter Human Use, the agency said.
Under the new guidance, FDA "does not intend to object to the marketing of products containing the following warning language:"
Allergy alert: acetaminophen may cause severe skin reactions. Symptoms may include:skin reddeningblistersrash If a skin reaction occurs, stop use and seek medical help right away.
Allergy alert: acetaminophen may cause severe skin reactions. Symptoms may include:
If a skin reaction occurs, stop use and seek medical help right away.
The language should be included in the "warnings" section of the product labeling, FDA said.
While the guidance is technically non-binding, FDA could object to the marketing of any product not containing the warning, preventing it from being sold.
Recommended Warning for Over-the-Counter Acetaminophen-Containing Drug Products and Labeling Statements Regarding Serious Skin Reactions (FR)
Tags: Acetaminophen, Draft Guidance, Labeling, Warning, Skin Reactions
Regulatory Focus newsletters
All the biggest regulatory news and happenings.