About the Author
My name is Mark Senak. I’m a lawyer and I work at the international communications firm FleishmanHillard in New York. For the past several years, I have been consulting with pharmaceutical and biologic companies that are engaged in the process of bringing new drugs to market. I have also worked extensively with an array of medical societies and patient organizations providing strategic communications counsel and media training.
Category Archives: Approval Announcements
PDUFA Dates, AdComms and Approvals – 2018 So Far
There would seem to be a momentum for new approvals brought on by a number of circumstances, not the least of which is the fact that last year saw a record number (47) of approvals for new molecular entities (NMEs), … Continue reading
Posted in Approval Announcements
Comments Off on PDUFA Dates, AdComms and Approvals – 2018 So Far
The Convergence of Digital Health, Devices and Pharma
There has been a huge push in policy circles to speed innovation in medicine which is manifest in several initiatives, including most notably the 21st Century Cures Act implementation. But it would be a mistake to assess the quickening pace … Continue reading
Posted in Approval Announcements, Medical Apps, Medical Devices
Comments Off on The Convergence of Digital Health, Devices and Pharma
The White House on FDA Approval Burden – Is There a There There?
In his remarks to a joint session of Congress delivered this week, President Trump expressed the point of view that the “slow and burdensome approval process at the Food and Drug Administration keeps too many advances… from reaching people in … Continue reading
Posted in Approval Announcements, FDA Image, FDA Policy
Comments Off on The White House on FDA Approval Burden – Is There a There There?
FDA – Fewer Approvals, Less to Talk About in 2016
As the year ends, it is time to look back at what has occurred during the year and what hasn’t. Let’s begin with approvals. I noted recently in a Tweet that during the months of October and November, FDA had … Continue reading
Posted in Approval Announcements, FDA Image
Comments Off on FDA – Fewer Approvals, Less to Talk About in 2016
FDA 2015 Report on New Drug Approvals – A Banner Year
Greetings from the big blizzard of 2016. With life in the slow lane for a bit, it was a good time to catch up on reading. One of those was a recently issued FDA report on the novel new drugs … Continue reading
Posted in Approval Announcements, FDA Policy
Comments Off on FDA 2015 Report on New Drug Approvals – A Banner Year