Blog Profile / Eye on FDA


URL :http://www.eyeonfda.com/
Filed Under:Medical / Pharmaceutical
Posts on Regator:330
Posts / Week:1.4
Archived Since:November 3, 2010

Blog Post Archive

FDA Enforcement of Digital Communications – An Update

In 2013, I published a white paper called “FDA Communications Oversight in a Digital Era” that drew upon the data base I had put together of OPDP Warning and Untitled Letters (referred to collectively as “regulatory action letters”). The object … Continue reading ?

Weekly Roundup 6.19.15

No postings this week – sorry about that – travel and business, but will shoot for some good ones next week. This was another week of tropical rain – the kind that comes and dumps steady water as if a … Continue reading ?

Weekly Roundup 6.12.15

It is as if the calendar just knows when to turn up the heat. We have crossed over into the second week of June and already we face days that head into the 90s and late afternoon thunderstorms that characterize … Continue reading ?

Live Streaming – Game Changer for AdComms and Beyond?

This week there was a lot of talk about last week and the meeting of the American Society of Clinical Oncology annual meeting ASCO 15, which was the 51st annual meeting of the society held May 29 – June 2 … Continue reading ?

Weekly Roundup 6.5.15

It has been a week of rain and gloom in our nation’s seat of government. It has been cold, gray and unpleasant. Commutes are nasty. The lack of sunshine is getting serious. But on the bright side, pollen has been … Continue reading ...

Regulatory Considerations in Optimizing a Site for Mobile

Fact: One of the primary uses of the Internet is to seek health information. Fact: By 2015, nearly two-thirds of Americans now have a smart phone; Fact: Of those owning a smart phone, 62 percent have used their phone in … Continue reading ?

Weekly Roundup 5.29.15

In spite of the fact that summer does not officially begin until the Summer Solstice which will occur on Sunday, June 21, if you are like me and many others the unofficial beginning of summer happens on Memorial Day. And … Continue reading ?

Advisory Committee Track Records

Needless to say, every time a product goes before an FDA Advisory Committee (AdComm), there are circumstances that make the deliberations that occur during that meeting a unique experience. A specific investigative compound being studied for a specific indication with … Continue reading ?

Weekly Roundup 5.15.15

Today is one of those days where if you took the date and read it backwards – 5.15.15, it would still be the same date and it has pretty much been that way all week. 5.14.15, 5.13.15 and so on. … Continue reading ?

The Guidance that Dare Not Speak Its Name

In December 2014, Commissioner Hamburg announced a proposed change in the FDA’s long-standing policy regarding blood donations from gay men – See “FDA Commissioner Margaret A. Hamburg’s statement on FDA’s Blood Donor Deferral Policy for Men Who Have Sex With … Continue reading ?

Weekly Roundup 5.8.15

It is one of my three favorite times of year – the days are so much longer – the evenings cool and pleasant for sleeping near open windows – the mornings crisp and the afternoons languidly warm. Flowers abound. There … Continue reading ?

Weekly Roundup 5.1.15

Happy May Day! As much of the world celebrates the worker, here we toil to bring you this week’s latest. We are well into the second quarter of the year – hard to believe – and are having those kinds … Continue reading ?

FDA Press Releases – 1st Quarter 2015

Last year I began a new database that tracks the press releases of FDA as a way to see what news the agency is talking about and provided a year end look at 2014. Looking back at the quantity and … Continue reading ?

Weekly Roundup 4.24.15

It is that time of year when the temperatures can range by 30 degrees from morning until afternoon. The pollen counts are high and already sudden storms appear on the horizon to dump a lot of rain and then move … Continue reading ?

The Regulation of Search

Where are we when it comes to the regulation of search and digital media by FDA? After issuing some guidance documents, we know a little more about FDA’s approach to digital and social media, but there are still many outstanding … Continue reading ?

Weekly Roundup 4.17.15

A few weeks ago it snowed, this week the lawn mowers were revved up. The car is covered in pollen. The cherry trees in DC have peaked. The ranks of tourists have swollen. Taxes have all been done and filed … Continue reading ?

Warning and NOV Letter Summary – 1st Quarter 2015

In the years past when the Office of Prescription Drug Promotion (OPDP) issued Warning Letters (WL) and Notice of Violation (NOV) letters with regularity, it was the custom here at Eye on FDA to review them on a quarterly basis. … Continue reading ?

Weekly Roundup 4.3.15

March winds bring April showers. April showers bring May flowers.  May flowers bring pilgrims. Ha. It is April – 2015 speeds at a breath-taking speed. The yard work continues to wait, but the daffodils do not and have arrived in … Continue reading ?

Weekly Roundup 3.27.15

Another busy week – hence a day late with the Weekly Roundup. This week, I cleared one of the flower beds of the dead stems from winter and filled three lawn and leaf bags with leaves and stems.  They took … Continue reading ?

Is Bigger Safer? OPDP Enforcement Patterns and Company Size

Eye on FDA has frequently carried overviews and summaries of enforcement by the Office of Prescription Drug Promotion (OPDP) through the issuance of Warning and Untitled Letters (regulatory action letters). These letters, along with guidance documents that are occasionally issued … Continue reading ?

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