New in Departments

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: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...

RE:Timing of Self-identification and GDUFA Fees
Posted: 4/22/2014 9:05:36 AM
From : Discussion Post>>Regulatory Open Forum
There are a few links on FDA.gov that I hope you find helpful. This link (Generic Drug User Fees) contains further links to other documents including this FAQ . There is also a Technical Walk-Through and Live Question and Answe...

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