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.
Your membership opens the door to free learning resources on demand. Check out the Member Knowledge Center for free webcasts, publications and online courses.
Hear from leaders around the globe as they share insights about their experiences and lessons learned throughout their certification journey.
RAPS recognizes that the current situation in Ukraine impacts our members and customers on many levels. If you are directly impacted by the current situation in the region and are challenged to meet your deadlines or obligations to RAPS, please reach out to raps@raps.org so that we can defer those challenges. Your health and safety are paramount to us.
Posted 26 September 2016 | By Zachary Brennan
The US Food and Drug Administration (FDA) is seeking comment from interested stakeholders to determine the utility of a list of examples of biomarkers used as outcomes in development of FDA-approved new molecular entities and new biological therapeutics.
The comments, which should be submitted by 18 November, may assist FDA in developing databases on biomarkers for drug development in the future, the agency said.
Biomarkers are frequently used in support of drug development, particularly as an outcome in a clinical trial.
FDA offers a look at biomarkers used in 12 therapeutic areas – including cardiology, oncology and infectious disease – that were accepted and used as outcomes in clinical trials as the basis for drug and biologic approvals from October 2007 to December 2015.
However, FDA notes that the appropriateness of the use of any particular biomarker as an outcome in one drug program should not be assumed to be appropriate for use in a different context or for a different drug development program. Therefore, drug sponsors are encouraged to consult with the relevant FDA review division as early as possible in drug development regarding the use of a particular biomarker in their planned clinical trials.
FDA is now soliciting suggestions and comments to determine the utility of the biomarker outcomes list and to identify any areas where more information can be disseminated on biomarkers that have been used to support the approval of drugs or biologics. Specifically, FDA wants to hear about:
Federal Register
Tags: biomarkers, biomarker examples, clinical trial biomarkers, FDA and biomarkers