Blog Profile / Eye on FDA

Filed Under:Medical / Pharmaceutical
Posts on Regator:458
Posts / Week:1.2
Archived Since:November 3, 2010

Blog Post Archive

Weekly Roundup 12.8.17

Given the early arrival of Thanksgiving this year, it should have been a long shopping season, but the walls are already closing in. The days are still growing shorter. The trees and decorations have gone up. We are all in … Continue reading ?

Weekly Roundup 12.1.17

Today marks the 30th World AIDS Day. It is at the same time breathtaking and heart breaking to note the progress made during the course of this epidemic. In that first year, there were no treatments for HIV/AIDS, transmission was … Continue reading ?

A Manner of Speaking

During all of last year, FDA issued 18 “general announcements” via press release to discuss agency actions on policy issues, announce a point of view or enunciate a policy issue. Two of those from last year included statements that came … Continue reading ?

Weekly Roundup 11.17.15

We have no sooner gotten rid of the candy from Halloween then we are preparing to receive our Thanksgiving guests and putting together menus for the big day, only to rush headlong into the next holiday season that will involve … Continue reading ?

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 ?

Weekly Roundup 11.10.17

Phew – candy handed out and leftovers gobbled up at the office. I am safe. Now comes the rather heavy preparation for Thanksgiving to receive guests and prepare feasts. That, combined with extreme business foreclosed an intermediate posting this week … Continue reading ?

Weekly Roundup 11.3.17

We are finally about to Fall Backward!  Don’t forget to set your clock back this weekend to mark the end of Daylight Savings Time as we once again return to dark early evenings and even in December – dark late … Continue reading ?

OPDP Enforcement Letters at Record Low

The Office of Prescription Drug Promotion (OPDP), once known as the Division for Drug Marketing, Advertisting and Communications (DDMAC) monitors company communications about medical products and when it deems those communications have gone outside regulatory parameters, the office issues a … Continue reading ?

Weekly Roundup 10.27.17

The leaves are falling around us and still no first frost. And we are just a few short days from the knocks at the door by young and sometimes not so young seeking sugar handouts while dressed in costume. If … Continue reading ?

Weekly Roundup 10.20.17

The first frost on the pumpkin is not far away. The garden is beyond tired and leaves are filling the gutters. I find myself craving comfort foods and am anxious for that first fire in the fireplace. Time marches on, … Continue reading ?

Is FDA Set for Another Banner Year of Approvals?

In 2015, FDA experienced a banner year with respect to the number of novel drugs and biologics that were approved by the agency – 45 all told. Since then, the 21st Century Cures Act was passed with the goal, among … Continue reading...

Weekly Roundup 10.13.17

It is Friday the 13th – one of two this year (the first was in January) and we sit a few weeks away from Halloween. Pumpkins on porches this month, in pies next month.  A few weeks ago you may … Continue reading ?

Weekly Roundup 10.6.17

We are already arriving at Columbus Day Weekend. The year has gone by breathtakingly fast from my perspective. We are only a month away from changing the clocks, but it will be here before you know it. I am already … Continue readin...

Weekly Roundup 9.29.17

Everyone has returned from vacations and extended vacations and are cramming to get business done before the year end string of holidays. There is been a good deal of activity this week, so let’s get right down to it.  FDA … Continue reading ?

Weekly Roundup 9.22.17

Today marks the beginning of autumn and the summer of 2017 is over. The first turning of trees has begun and leaves and acorns are dropping on lawns. The linens have left our closets and we are beginning to think … Continue reading ...

New FDA Directions – Part 3 – Opioids

In this third, and final installment on new directions for FDA under the watch of a new Commissioner, we turn to the issue of opioids. When Dr. Robert Califf was being considered for confirmation as FDA Commissioner he faced a … Continue reading ?

Weekly Roundup 9.15.17

One season winds down, another offers hints of a beginning. I am afraid that both the regular Weekly Roundup as well as regular postings have lately been interrupted by some domestic issues that came up for me as well as … Continue reading ?

Weekly Roundup – 9.1.17

As hurricane season made itself felt this week, summer seems over in the east. Kids are back to school and this weekend summer whites and linens have their final appearance before next Memorial Day. Meanwhile it was a very busy … Continue reading ?

My Moment with Jay Thomas

A departure from the usual FDA fare. The blog is meant to cover FDA issues, but also various aspects of communications. This is a story about media training, sort of. Jay Thomas died yesterday. He was 69 years old. He … Continue reading ?

Weekly Roundup 8.11.17

I’ve decided to bring back the Weekly Roundup. I have missed it and especially now with the prospect of a good deal of change in healthcare in general and FDA in particular, much more is happening than I would ever … Continue readin...

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