Clik here to view.
Development Pathway for Devices
There is often the question of “how different is the development pathway for devices than for drugs?” Even for those of us on one side of the industry, we may know a little, but perhaps not as much as...
View ArticleClik here to view.
Book: Biodesign – The Process of Innovating Medical Technologies
For those in the medical device industry, those looking at devices, and/or others just curious, Cambridge University Press recently published a new book, Biodesign – The Process of Innovating Medical...
View ArticleClik here to view.
Are you (seen as) the expert?
This came across my desk today from a vendor. It is most directly relevant to those of us in the device world, but it also begs the question more broadly – are we seen internally in our companies as...
View ArticleClik here to view.
Pharma 2020 Series (PWC)
For those that missed it earlier this year, PriceWaterhouseCoopers published the fifth installment in its Pharma 2020 series, which discusses what the Pharmaceutical landscape will look like in the...
View ArticleClik here to view.
FDA Launches New Device Transparency Web Site
In an ongoing effort to provide more transparency, the FDA has launched a new website to provide information about medical device and radiation-emitting product regulations and decisions. Part of the...
View ArticleClik here to view.
FDA Transparency Initiative: Draft Proposals for Public Comment
Find the draft proposals here. From Dr. Sharfstein at the FDA: Last summer, FDA Commissioner Dr. Margaret Hamburg launched the Transparency Initiative. It has been my pleasure to chair an internal task...
View ArticleClik here to view.
Roundup from the past week
Catching up on items that might be of interest in the past week: Elsevier acquires Collexis, a leading developer of semantic technology and knowledge discovery software for research and development...
View ArticleClik here to view.
Genetic tests = medical devices
Under the category of “what is a medical device?” – according to the FDA, one should include genetic tests such as those from 23andMe and deCODE GEnetics.Filed under: Medical Devices / Diagnostics
View ArticleClik here to view.
FDA’s Current Thinking on Social Media and Product Promotion
For those of us in the industry, we know that social media has been much slower to adopt than in other industries. And for some obvious reasons, FDA constraints on promotion being one of them. Areta...
View ArticleClik here to view.
Combination Products – A whitepaper on FDA GMP regulations
For those interested: Over the past 12 months, the FDA has developed streamlined regulations for Good Manufacturing Compliance (GMP) for combination products. This paper reviews those guidelines and...
View Article
