Stay Up-To-Date With Industry Happenings
Our Client Alerts are our way of sharing current regulatory news and insights with our clients and friends of the firm. Our mailing list is huge and many of our Client Alerts are turned into trade press articles upon a media request to do so.
We pride ourselves in not publishing the pablum that everyone else says about a new law, regulation, guidance or regulatory initiative.
We bring to bear our experience, FDA relationships, our constant interface with FDA in meetings, phone calls and email communications to give you "inside baseball" insights into what it all means.
- Published on: February 18, 2020
In this second installment of our three-part series, we cover the more technical aspects and strategies behind a Pre-Sub. In this installment we review the decision of whether to have a Pre-Sub or not, how to persuade FDA to your position in writing a Pre-Sub request, and some preliminary thoughts about how to prepare for a Pre-Sub.
- Published on: January 20, 2020
In this three-part series, we will explore the strange world of FDA Pre-submission meetings through the metaphor of the Addams Family—the popular 1960's TV comedy. You remember the characters—the patriarch and matriarch, Gomez and Morticia, who play the Office and Division Directors at FDA who in their running of the household are completely unaware that their family just doesn't fit into the real world, that people are afraid of their ways, and don't understand their intentions---which are often out of sync with the world outside their home. Their children Pugsley and Wednesday, who are played by the reviewers at FDA, find creative ways to torture and play menacingly with sponsors. Then there is Uncle Fester as the Chief Medical Officer who explores creative new scientific theories for exploding a sponsor's submission. Cousin It is played by the biostatisticians who speak unintelligibly and scurry in and out of a submission distracting from the focus of what needs to be done. Thing is played by the FDA's outside consultants who seem to have a hand in everything but frequently disappear only to reappear and attract attention-grabbing ideas that derail the discussion. Grandma is played by the Ombudsman, eccentric and often not present or even that helpful, but always beloved. And then there is Lurch, the Consumer Safety Officer, your escort when you need to visit the Addams family home, who shows disapproval by shaking his head and communicating in grunts and groans. Finally, they live in this spooky mansion, Building WO66, filled with this odd cast of characters. The family gives sponsors a warm reception upon arrival, but they are thoroughly examined before entering and a sponsor walks through the halls with great trepidation holding a tense smile with unease not knowing exactly what is going to happen next, for the experience is strange and unfamiliar.
© Silar (Wikimedia Commons)
- Authored by: Mark DuVal, Beth Luoma, Jeff Zumhofe, Lisa Pritchard, Aaron Hage, Greg Spar, Mimi Passalacqua
- Published on: December 17, 2018
What changes will the new year bring?
The medical device industry is ever-evolving. Our experts weigh in on what they expect to see from industry in the new year in this Client Alert. With each of our specialists commenting on their specific areas of expertise, this is a Client Alert that shouldn't be overlooked by anyone engaged in regulatory affairs.
Continue reading to see what each of our in-house regulatory affairs experts expect to see in 2019, within their particular disciplines.
- Authored by: Mark DuVal
- Published on: November 2, 2018
Cybersecurity services we offer
As new applications of technology and data transmission emerge in the medical device industry, so does the ever-present threat of unauthorized access to related datasets and/or the underlying systems.
With over 20 years of experience working with industry, our in-house medical device software and design consultant, Greg Spar, is well-versed in what it takes to build a secure medical device.