Blog Profile / Eye on FDA

Filed Under:Medical / Pharmaceutical
Posts on Regator:412
Posts / Week:1.3
Archived Since:November 3, 2010

Blog Post Archive

Weekly Roundup 9.30.16

The shifting of gears is happening before our eyes. Already leaves are falling and the morning alarm goes off in the final moments of night time darkness rather than the first rays of morning sunshine. The trees are signalling that … Continue reading ?

Breakthrough Therapy Status, AdComms and Approvals

In recent years FDA has undertaken several means to facilitate the consideration of new drug applications by creating various mechanisms for expedited review for either new drugs or new indications for existing drugs. Prior to 2012, there had long been … Continue reading ?

Weekly Roundup 9.16.16

Kids are back in school. The air is kinder, gentler and less harsh than the last heated days of summer, though summer tries to hang on some days, it is ebbing into Autumn. Halloween candy has already appeared in stores. … Continue reading ?

Weekly Roundup 9-2-16

The end of summer. This is less like a Weekly Roundup than a Monthly Roundup. Like everyone else, I have taken August with a grain of salt. It feels a little lonely writing blog postings when you know that readers … Continue reading...

This is Your State, This is Your State on Drugs

I always enjoy doing a periodic check in on what states are doing when it comes to healthcare issues. Utilizing the excellent data base resources at the National Conference of State Legislatures, one can examine numerous categories of legislation that … Continue reading ?

AdComm Recommendations – How Often FDA Does Not Follow Them?

When an FDA Advisory Committee meets and deliberates whether or not the new drug application put before the agency should or should not be approved, they gather together and deliberate in a public forum often for hours. Prior to the … Continue reading ?

Weekly Roundup 7.29.16

The lawn is a lovely shade of brown. What can one say after that? The hot, humid days always evoke for me very strong childhood memories when the days were long and the season far too short and time was … Continue reading ?

Weekly Roundup 7.22.16

Well, it is really hot. Really really hot. And I am moving kind of slow, as one should probably do in the summer. I didn’t even get to the Weekly Roundup last week, which means that some of what I … Continue reading ?

More or Less – A Look at FDA Press Releases at Half Year

What do FDA press releases for the year say about the rate of new approvals for 2016? Periodically I take a look at what FDA has said – and a little bit conversely at what it hasn’t. In April, I … Continue reading ?

Weekly Roundup 7.8.16

Perhaps it is a throwback to childhood, but summer always seems to go by faster than other seasons. And this summer is no exception. Sunflowers are blooming, daisies are beaming, lawn mowers are mowing. It seems everywhere you look, summer … Continue reading ?

Pharma Twitter Activity

I recall a time when the head of a regulatory department of a pharmaceutical company told me that the company would never, ever, ever under any circumstances be involved in social media. By my count, today that company has twenty-one … Continue reading ?

Weekly Roundup 6.17.16

We are enjoying more respite from heat here in the mid-Atlantic. Certainly a difficult week that brought reflection and sadness for many. And so we’ll get right down to some of the things that happened FDA-related that were noteworthy: Tragedy … Continue reading ?

Weekly Roundup 6.10.16

We are finally getting some weather that could be described as delightful.  I hope that you are too. The grass is green, a breeze blows and there is lots of birdsong in the air. For the first time in years, … Continue reading ?

Weekly Roundup 5.27.16

Weekly Roundups have been in absentia for the past few weeks. Forgive me – it has not been for lack of wanting to get the job done, just time. May began with a serious bout of the flu. While it … Continue reading ?

The Drop in OPDP Enforcement

Back when the Office of Prescription Drug Promotion (OPDP) issued regulatory action letters on a regular basis (either Warning Letters or Untitled Letters) regarding what the agency saw as infractions in the course of promotional speech, I would post a … Continue reading ?

More Space on Twitter – Does it Change Things for Pharma?

This week media carried reports that Twitter was going to making a shift in policy regarding space. Until now, you have been limited to 140 characters in your tweeting which included space for your – albeit tiny – URL and/or … Continue reading ?

Which Way on the Public Health Narrative on Zika?

Back in February in a post entitled “From HIV to Zika – The Role of Communications“, I listed several of the hallmark characteristics involving the communications environment and emerging pathogens, drawing not only on recent observations with respect to Ebola, … Continue reading ?

Weekly Roundup 4.29.16

Goodbye April. It was nice knowing you. There were a lot of noteworthy developments this week and I would like to write about them all, but as usual, will pick only a few from the bunch. FDA Issues Complete Response … Continue readi...

What Pharma’s Are Doing on Periscope – Update on the Landscape

If you have Periscope on your phone, you may find yourself doing something and all of a sudden, hear a little whistle that is the sound cue to let you know that someone you follow has gone live. I set … Continue reading ?

Weekly Roundup 4.22.16

A few weeks ago it was snow, now it is pollen – laden everywhere. Dogs, cars, outdoor seating, all covered in a fine yellow haze. Or is that me? I have had such a busy week that the result has … Continue reading ?

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