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 02 January 2018 | By Zachary Brennan
Know the difference between a Type A, Type B and Type C meeting with the US Food and Drug Administration (FDA)? New draft guidance released last week will help biopharma companies understand how to conduct such meetings and what to expect.
The 20-page draft explains how sponsors can submit a formal request for a meeting, which can be face-to-face, teleconference/videoconference meetings or written responses only, what sponsors should include in that request, how FDA can respond, how long the agency can take to respond, and how the sponsor and FDA can go about conducting efficient, consistent, timely and effective meetings.
The draft also discusses premeeting preparation, the contents of a meeting package, what kind of preliminary responses (which FDA says, “should not be construed as final unless there is agreement between the requester and the FDA that additional discussion is not necessary”), rescheduling and canceling meetings, and meeting conduct and minutes.
In terms of meeting denials, FDA explains: “For example, a meeting can be denied because it is premature for the stage of product development or because the meeting package does not provide an adequate basis for the meeting discussion. Thus, the FDA will generally deny requests for Type A meetings and Type C meetings to discuss the use of a biomarker as a new surrogate endpoint that has never been previously used as the primary basis for product approval that do not include an adequate meeting package in the original request.”
Meeting goal dates and timelines were also outlined in an appendix:
The draft comes as stakeholders have recently weighed in on draft guidance related to formal meetings between FDA and abbreviated new drug application (ANDA) sponsors, and back in 2015, FDA finalized guidance on formal meetings with biosimilar sponsors.
Formal Meetings Between the FDA and Sponsors or Applicants of PDUFA Products: Draft Guidance for Industry
Tags: formal FDA meetings, PDUFA VI, user fee goal dates for meetings, Type A meeting
Regulatory Focus newsletters
All the biggest regulatory news and happenings.