FDA Takes Steps to Align with GHTF23 Mar 2012

In June 2012, the United States Food and Drug Administration will pilot a program allowing medical device manufacturers to submit ISO 13485:2003 quality system audits to satisfy the FDA 21 CFR Part 820 inspection requirements for one year.   The FDA...

FDA Issues a guidance on their position on the use of social media6 Feb 2012

Drug and device makers have asked for regulators to issue rules on the use of social media. Earlier this year, the FDA issued a draft guidance to address how companies should respond to certain requests for information on off-label use of products. A...

CMC Decision on Medical Device Labeling31 Jan 2012

The Central Management Committee (CMC) on Medical Devices, formed in 2010 to improve the effectiveness of regulations in the EU, has issued a decision on medical device labeling. The decision is as follows: The ‘address of the manufacturerR...

‘No need to translate. Everyone speaks English here.’15 Sep 2011

There was an interesting article in the Times of India this week. It appears that there has been some fallout over certain CROs using patients that were not completely aware of the clinical trial they were entered into. Indeed, the vast majority of t...

FDA proposes guidance to clarify risk-benefit determinations for medical devices16 Aug 2011

The U.S. Food and Drug Administration has provided draft guidance clarifying how benefit-risk determinations are made during premarket review of certain medical devices. The guidance focuses on premarket approval applications (PMAs), the regulatory p...

The importance of physics to progress in medical treatment - Laser Focus world20 Apr 2012

The importance of physics to progress in medical treatmentLaser Focus worldKey messages * Progress in the physical sciences (physics and engineering) substantially affects the life sciences, especially the progress of medical care.* Closer collaboration is needed between the two research sectors through a new paradigm of ...