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Perspective | 1 April 2014
Elisabeth Kübler-Ross identified the five stages of grief as denial, anger, bargaining, depression and acceptance. Regulatory submissions are really no different. Read more »
Perspective | 28 March 2014
Baseball: America's favorite past time, and strikingly similar to the world of pharmaceutical advertising and promotion. Read more »
Under RAPS | 10 April 2014

RAPS announces the establishment of a new chapter in Taiwan, its first in Asia.

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Under RAPS | 9 April 2014
RAPS is seeking applicants who want to make a difference in the regulatory profession as members of the 2014 Class of RAPS Fellows. Read more »

Regulatory Update

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Brazil’s national regulatory agency, Anvisa, has expedited the process for importing high-risk medical devices (Class III and IV) by agreeing to review devices as soon as its foreign manufacturing Read more »

The European Medicines Agency (EMA) announced on 8 April 2014 that it plans to launch a final round of meetings in May with organizations representing patients, academia, the pharmaceutical industry Read more »

Health Canada issued revised product monograph guidance on 4 April 2014 that sets forth new design and format requirements, and also includes a new section on preparing patient information. According Read more »

On 31 March 2014, the China Food and Drug Administration (CFDA) and China's State Council Legislative Affairs Office announced the first major overhaul of the regulations governing medical devices Read more »

Regulatory Exchange

Join the discussion -- RAPS Regulatory Exchange

RE:Risk-Based Biocompatiblity Assessment Timeframes?
Posted: 4/19/2014 8:14:55 PM
From : Discussion Post>>Regulatory Open Forum
Julie, With the notion that a device is subject to few to many biocomp studies. So timelines from A to B can quite vary from 2 weeks to several months and ever over a year. The risk assessment itself can be easily done in a wee...

RE:Risk-Based Biocompatiblity Assessment Timeframes?
Posted: 4/19/2014 1:32:46 PM
From : Discussion Post>>Regulatory Open Forum
I'm afraid I didn't ask my question very clearly, for which I apologize. For people with experience with ISO 10993 risk-based biocompatiblity assessment with new devices, I would like to know about how much PROJECT time it takes to g...

RE:Career Advice
Posted: 4/18/2014 3:19:35 PM
From : Discussion Post>>Regulatory Open Forum
I would say that one of the best and fastest ways is to keep plugging with other professionals while building and sharpening your skills and knowledge. While doing so, if you are able to develop these three key attributes (I wrote...

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