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Key Regulatory Topics: The eCTD
2014 RAPS: The Regulatory Convergence
RAPS Learning Solutions
RAPS Store - The source for regulatory knowledge
RAPS Executive Development

RAPS & Regulatory

RAPS is the largest global organization of and for those involved with the regulation of healthcare and related products, including medical devices, pharmaceuticals, biologics and nutritional products. Founded in 1976, RAPS helped establish the regulatory profession and continues to actively support the professional and lead the profession as a neutral, non-lobbying nonprofit organization. Read more »

 Upcoming Events
Event: Chapter

Chapter Event
Key Enforcement, Legal, Regulatory and Policy Updates
24 April 2014 | Bridgewater, NJ

Event: Chapter

Chapter Event
Spring Networking Reception
24 April 2014 | Sandy Springs, GA

Event: Advertising, Promotion and Labeling: the US Regulated Environment

Virtual Program
Advertising, Promotion and Labeling: the US Regulated Environment
30 April 2014 | Online

Event: RAPS Executive Development

Workshop
RAPS Executive Development
2–5 June 2014 | Evanston, IL

Event: 2014 RAPS: The Regulatory Convergence

Conference
2014 RAPS: The Regulatory Convergence
27 September–1 October 2014 | Austin, TX


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 Community
Join the discussion -- RAPS Regulatory Exchange

RE:Risk-Based Biocompatiblity Assessment Timeframes?
Posted: 4/22/2014 2:34:00 PM
From : Discussion Post>>Regulatory Open Forum
Points to consider: Some GLP studies including biocomps have been found to be flawed. Thus, I recommend you carefully design and consider all key factors with mind to identify safety issues not for the sake of just doing it as part...

RE:EU Class I Device Clinical Evaluation
Posted: 4/22/2014 12:04:58 PM
From : Discussion Post>>Regulatory Open Forum
The MDD allows you to waive the clinical evaluation for devices where it is not appropriate: From Annex X: "Where demonstration of conformity with essential requirements based on clinical data is not deemed appropriate, adequate j...

RE:Timing of Self-identification and GDUFA Fees
Posted: 4/22/2014 11:01:08 AM
From : Discussion Post>>Regulatory Open Forum
Charles, Based on your description (for example, non-GMP, no ANDA submission), you don't seem to fall under five categories set out under GDUFA 2012 and Title III of FDASIA 2012. Please read the statutes and FDA guidance below. h...

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