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.
Registration is now open for RAPS Convergence 2021! Gather with the regulatory community 12-15 September for four days of learning, engagement, and excitement.
Keep the sparks coming! Delegates of the conference have access to on-demand content until the end of October 2021.
This updated edition is a great reference for anyone working in multinational product development and marketing.
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 28 March 2012 | By Alexander Gaffney, RAC
An analysis by the Biotechnology Industry Organization (BIO) of 748 new drug applications (NDAs) and biologics license applications (BLAs) shows a nearly 20% increase in the rate of approvals for second-round submissions in response to a first-round complete response letter (CRL).
The analysis, which tracked NDA and BLA submissions made between 2005 and 2010, shows a 55% approval rate for first-round submissions.
The total approval rate jumped nearly 20% to 74.6% after companies submitted responses to the US Food and Drug Administration's (FDA) CRLs. A third round of responses brought that percentage up an additional 8.3% to 82.9%.
From there, additional rounds of responses and submissions did not lead to significant increases in approvals. Fourth-round submissions increased the total by 1.2% (84.1%), and a fifth round of submissions only improved the total by 0.2% (84.3%).
"After [the third-round submission]", writes BIO, "there is little data to support that subsequent submissions materially impact the probability of approval."
The analysis sheds some light on the importance of regulatory quality in filings, and provides insight on FDA's drug approval ceiling and filing strategies.
"When we analyzed 83 NDA/BLA filings that never made it to approval (i.e. were finally suspended by the sponsor), only one was attributed to a manufacturing issue," writes BIO.
Read more:
BIO - Dealing with Rejection, the Regulatory Kind
Tags: Rate, Approved, CRL, BIO, BLA, Latest News, pharmaceutical, biologic, approval, NDA, drug
Regulatory Focus newsletters
All the biggest regulatory news and happenings.