Blog Profile / Eye on FDA

Filed Under:Medical / Pharmaceutical
Posts on Regator:474
Posts / Week:1.2
Archived Since:November 3, 2010

Blog Post Archive

Weekly Roundup 3.23.18

At least here in the mid-Atlantic region, the ground hog appears to have got it wrong, with a week that had quite moderate temperatures. In the herb garden, the chives have popped up, always a harbinger of Spring. I tried … Continue reading ?

Weekly Roundup 2.16.18

This week we had 70 degree temperatures and predictions of snow. It seems we are living in roller coaster times – at least for this month. For all the lovers out there, hope the Valentine’s Day was second to none. … Continue reading...

FDA’s Strategic Policy Roadmap – Part 2 Addressing Addiction

With deaths rising each year, there is no question of the urgency that something needs to be done to address the opioid misuse epidemic in the United States. And in addition to mortality there are the lives touched by these … Continue reading ?

Weekly Roundup 2.9.18

February. When the inconvenient bursts of weird precipitation, the cold and the dark starts really getting on your nerves. They made it the shortest month for a reason. Facing the prospect of yet another government shutdown, it appeared that at … Continue reading ?

FDA’s 2018 Strategic Policy Roadmap, Part 1

In January, FDA’s Commissioner announced the release of “Health Innovation, Safer Families: FDA’s 2018 Strategic Policy Roadmap” that provides a detailed overview of priorities for the agency within a relatively short timeframe. FDA and the various centers that make up … Continue reading ?

Weekly Roundup 2.2.18

Groundhog Day is happening today to bring us the valuable insight related to the length of winter and the beginning of Spring. Exciting, but not as thrilling in my mind as the re-establishment of Daylight Saving Time when the hours … Continue reading ?

Weekly Roundup 1.26.18

The funding kerfuffle came and went. Order was restored to the universe after a brief blip shuttered federal agencies, FDA among them, for a single work day.  It almost seems like a distant memory already, until next time. The weather … Continue reading ?

Is FDA Running Out of Juice on Social Media?

FDA held a public meeting in April 2009 on the regulation of promotional speech on social media by medical product manufacturers and set the framework for the discussion (and the subsequent regulation) by asking five questions. Ostensibly guidance was to … Continue reading ?

What They Said – FDA Press Releases 2017

Keeping our eye on FDA press releases as one measure of the way FDA talks to us is a regular feature here on Eye on FDA and there is no better time to look back than when we begin a … Continue reading ?

Weekly Roundup 1.19.18

As noted below, next week the Senate HELP Committee will hold Part 2 of a hearing series on public health threats in the 21st Century. Ironically this comes at the same time we are facing a series of deadlines to … Continue reading ...

Taking a Peek at Transparency – An FDA Pilot Program

Yesterday, Commissioner Scott Gottlieb announced a new effort on the part of the agency aimed at increasing transparency around clinical trials, a goal long sought by many patient advocates, particularly outside the U.S.  Specifically, FDA is introducing a pilot program … Continue reading ?

Weekly Roundup 1.12.18

As we ease into the new year cycle, 2018 is still waking up. Many of FDA’s web pages are not yet updated to reflect that the new year even exists. The weather is erratic, with low low temperatures one day … Continue reading ?

Advisory Committee Activity for 2017

Having worked with a lot of companies to prepare for an FDA Advisory Committee (AdComm), I track the activities of the committees in a database marking outcomes, votes and other characteristics. As part of a look-back series as we … Continue reading ?

Weekly Roundup 1.5.18

Welcome to the first Weekly Roundup of the year! The fact that it was a short week and one in which the East Coast and a good deal of the South were experiencing a weather challenge means that there was … Continue reading ?

Biggest FDA Developments for 2017

As we begin the new year, it is time toassess the previous year and consider what really mattered when all is said and done. We’ve perhaps already done this on a personal level, but here is my take on an … Continue reading ?

Weekly Roundup 12.15.17

This is it folks, the final stretch. Winter will arrive next week. Travel plans are underway. The last of the gifts are being bought and prepped for the big wrap. And speaking of wrapping up, there are a number of … Continue reading...

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 ?

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