Tag Archives: FDA

FDA – EMA mutual recognition of inspections of medicines manufacturers enters operational phase


1 November 2017 marks the coming into operation of further aspects of the mutual recognition agreement between the European Union (EU) and the United States (US) to recognise inspections of manufacturing sites for human medicines conducted in their respective territories. This agreement, which updates the agreement from 1998, allows for recognition of each other’s inspection outcomes and hence for better use of inspection expertise and resources.

In June, the European Commission confirmed that the US Food and Drug Administration (FDA) has the capability, capacity and procedures in placeExternal link icon to carry out good manufacturing practice (GMP) inspections at a level equivalent to the EU. Today, the FDA confirmed the capability of eight EU Member States (Austria, Croatia, France, Italy, Malta, Spain, Sweden, and United Kingdom). The remaining inspectorates will continue to be assessed until 15 July 2019.

Click here for more… (EMA)

Medicine is going Digital. The FDA is racing to catch Up

FDA going DigitalToday, machine learning powers more and more medical device software. And because it is always learning and improving, it is constantly changing products on the fly.
For most regulators, an ever-changing algorithm is their worst nightmare. But Bakul Patel is one of those rare Washington bureaucrats who’s also a fervently optimistic futurist. And he’s got big plans to get federal regulators off Washington time and up to Silicon Valley speeds.
To do that, the FDA is creating a new unit dedicated strictly to digital health. Patel will be hiring 13 engineers—software developers, AI experts, cloud computing whizzes—to prepare his agency to regulate a future in which health care is increasingly mediated by machines. Click here for more… (WIRED)

Digital Health

Digital HealthDigital Health is becoming the new frontier of the Digital Transformation due to its impact on social basis. To understand the importance of this field or research and business, consider big part of the investment put in place by pharma and healthcare companies all over the world: Johnson & Johnson built the technological incubator, GE Healthcare set up a brand new branch called Digital and more and more example could follow. Just to give you an idea of the impact, the FDA published a page (Mobile Health Apps Interactive Tool) to give precise advice on how to develop new technologies following the necessary regulatory aspect.

All these new applications would not been able to have this kind of technological increasing without the necessary basis: Cloud Computing, Big Data, Wearable Computing are the most important, without these “new tech” any possible development could be sometimes so expensive and some other probably technically impossible.

Last but not least the epidemiological studies which could be put in place via the big data analysis should have an incredible impact in terms of public safety control, to enhance efficiency in the healthcare, avoiding costs and losing time for the patients / operators, having as final results to save economical resource within the public health sector which is under enormous pressure since years.

What are the main areas of application?
• Wireless Medical Devices
• Mobile medical apps
• Health IT
• Telemedicine
• Medical Device Data Systems
• Medical device Interoperability
• Software as a Medical Device (SaMD)
• General Wellness
• Cybersecurity