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.
RAPS Euro Convergence brings regulatory peers from the EU and worldwide together in one forum to gain insights and exchange ideas on the region's most pressing issues. Register today to attend 10-12 May 2021.
Registration is now open for RAPS Convergence 2021! Gather with the regulatory community 12-15 September for four days of learning, engagement, and excitement.
With contributions from more than 30 authors from seven countries, the new edition incorporates a global overview of the field and is designed to help you get the most out of your regulatory intelligence endeavors.
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 February 2015 | By Alexander Gaffney, RAC,
The US Food and Drug Administration (FDA) is soliciting input on how it might accelerate the development of certain drug products through the use of new and emerging biomarkers.
In FDA's telling, a qualified biomarker—"an objective characteristic that is measured and evaluated as an indicator of normal biologic processes, pathogenic processes, or pharmacologic responses to treatment"—can help drug development in several ways.
For example, a biomarker might allow a company to more easily identify which patients would—and which would not—benefit from an experimental treatment. A biomarker might also allow a company to identify which patients would be harmed by a drug, or which patients need a different dose of a drug in order to benefit.
At FDA, the effort to identify appropriate biomarkers has traditionally focused on two areas: the identification of the biomarker as being useful, and the development of tools to capitalize on the identification of the biomarker.
FDA's argument has essentially been that while the identification of a useful biomarker is important, even more important is the application of that information to the development of new products.
To address this, in 2012 FDA created a new program known as the Drug Development Tools Qualification Program to qualify—i.e. validate as being useful and appropriate—new biomarkers, clinical outcomes, assessments and animal models.
The hope of the program is that the pharmaceutical industry will be able to accelerate the development of new therapies. For example, a company might use a biomarker to replace a drug's clinical efficacy endpoint or accelerate a testing phase.
"The path to development of promising therapeutics can be enabled by the availability of biomarkers that are analytically validated and clinically qualified for a specific context of use (i.e., a comprehensive, clear, and precise statement that describes the manner of use, interpretation, and purpose of use of a biomarker in drug development)."
FDA has said it also hopes the program will "foster" the development of new biomarkers and better integrate the use of qualified biomarkers into the regulatory review process.
To date, FDA has qualified four drug development tools based on biomarkers:
The biggest problem, FDA explains in a new Federal Register notice, is that it just doesn't have the resources to validate biomarkers on its own. To overcome this, the agency says it wants to work with private entities to help catalyze progress in the area. "Because of limitations in resources, such efforts must be focused on the opportunities that offer the greatest potential for impact."
"FDA intends to facilitate identification of the most promising biomarkers and the areas important to drug development and to promote efforts that will aid in the qualification and regulatory adoption of the drug development framework," it added.
The agency also wants the public's help to "identify promising biomarker candidates in areas important to drug development and to identify considerations for evidence needed to qualify various types of biomarkers for specific contexts of use."
Responses should include information about the biomarker, as well as a discussion about the specific aspects of drug development the biomarker could "enhance" and why the biomarker represents the "greatest near-term opportunity to establish utility in drug development."
Comments are due in 60 days.
FDA Request Notice
Tags: Biomarkers, Drug Development Tools, DDTs, Drug Development Qualification Program
Regulatory Focus newsletters
All the biggest regulatory news and happenings.