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.
The RAPS store will be under maintenance Saturday, 17 April between 5 AM and 12 PM EST. Store functionality may be unavailable at times during this window. We apologize for any inconvenience caused during this time.
Posted 05 March 2014 | By Alexander Gaffney, RAC,
Two new guidance documents just released by the US Food and Drug Administration (FDA) finalize recommendations for Biologics License Applications (BLAs) and Investigational New Drug Applications (INDs) submitted in support of minimally manipulated placental or umbilical cord blood intended to help treat patients with hematopoietic system disorders.
Hematopoeietic system disorders include ones affecting red blood cells (e.g. anemia), granulocytes (e.g. granulocytopenia), lymphocytes (e.g. lymphocytosis), monocytes (e.g. monocytosis), platelets (e.g. thrombocytopenia) and clotting proteins (e.g. hemophilia).
The guidance documents are intended for sponsors of products intended to treat those conditions - assumed by FDA to be cord blood banks, registries, transplant centers, and physicians serving as sponsor-investigators - who are preparing to submit either an IND application to start a clinical trial or a BLA to initiate FDA's review of a tested product.
Draft versions of both guidance documents were released in June 2013, meant to replace an earlier 2009 guidance on the same topic. As Rafael Cassata, RAC wrote in Focus, the guidance documents included new indications for use of hematopoietic progenitor cells (HPC) derived from cord blood, such as hematopoietic and immunologic reconstitution in patients with hematopoeietic system disorders.
Those changes came about as the result of a 2011 meeting of FDA's Cellular, Tissue and Gene Therapies Advisory Committee, Cassata recalled.
Even so, the indications only cover HPCs if they were "minimally manipulated." Further manipulation means they can be regulated as drug products, per recent legal decisions.
The guidance also goes on to clarify various clinical data requirements for BLA and IND application submissions.
Biologics License Applications for Minimally Manipulated, Unrelated Allogeneic Placental/Umbilical Cord Blood Intended for Hematopoietic and Immunologic Reconstitution in Patients with Disorders Affecting the Hematopoietic System (FR)
Investigational New Drug Applications for Minimally Manipulated, Unrelated Allogeneic Placental/Umbilical Cord Blood Intended for Hematopoietic and Immunologic Reconstitution in Patients With Disorders Affecting the Hematopoietic System (FR)
Tags: Hematopoietic, Cord Blood, HPC, Minimal Manipulation, Final Guidance, BLA, IND, Latest News, guidance
Regulatory Focus newsletters
All the biggest regulatory news and happenings.