It will be groundhog day this coming week. I know I will be watching to see what is predicted because I, for one, am done with the cold nature of this surly winter. Dog walks have been painful. Cars everywhere are covered in salt. And of course my biggest beef with winter – the days are short and there is no quality time on the front porch. In fact, there is no time on the front porch. I am sure many of you will be watching too. Let’s keep our fingers crossed.
In the meantime, it was a busy week for me and I did not get any postings up, for which I am sorry. I will endeavor next week to be more fruitful. Meanwhile, here is a little bit of what I thought I’d pass along from this week:
- First OPDP Letter of 2014 Posted – The first, and right now only, regulatory action letter from the Office of Prescription Drug Promotion was posted (technically last week, it appears, but only noticed by me this week). It was for a sales sheet and OPDP’s letter cited several issues with the promotional language. If you represent a product that is not intended for pregnant women, this is a letter you may want to check out to see how to avoid being dinged by the agency for broadening the patient population indicated in the label.
- FDA Issues Rule to Prevent Food Safety Risks During Transportation – The seventh and final major proposed rule to be announced under the Food Safety Modernization Act (FSMA) was issued this week by FDA that would require certain shippers, receivers and carriers transporting food by motor or rail to meet specific criteria for sanitary transportation. An example provided in the press release would be that shippers would inspect a vehicle for cleanliness prior to loading food that is not completely enclosed in a container – for example, fresh produce in vented boxes. This rule does not cover shippers who have less than $500,000 in annual sales. Three public meetings are scheduled around the country to discuss the proposed rule and the public comment period runs through May 31.
- Preparing for Advisory Committee – In case you are interested, I will be presenting next week at the CBI conference – the 5th Annual Effective Preparation for FDA Advisory Committee Meetings on February 6 here in Washington, D.C. I will be presenting on non-clinical aspects of preparation – so please say hi if you are there. I will be covering panel intelligence and issues mapping as well as various aspects of pre-approval communications.
That’s it for me after this cold week. Stay warm and be well and have a good and restful weekend. Groundhog, do your stuff!
Many regular readers might remember last September when I was able to share the news that a friend had named a new born calf after me – Marky! Well, Marky is growing up and here she is – pictured behind this fine young man in front – showing off her beautiful cow eyes.
It is hard to believe that January is almost over and that we are all still trying to get used to writing 2014 instead of 2013. Actually, truth be told, I am still in the 1990s. But as the rest of the world moves on, here is a bit of what happened this week:
- FDA Issues New Guidance on Dear Healthcare Provider Letters – This week the agency announced the availability of a new guidance entitled “Dear Health Care Provider Letters: n Improving Communication of Important Safety Information” meant to provide recommendations on the content and format of these missives to convey important information about a drug or to set about correcting misinformation. Contained in it are recommendations on when to issue a letter, the types of information in it and organization and format information. Interestingly, this is issued in the same week FDA postponed a Risk Communications Advisory Committee meeting that had been scheduled to identify the impact and reach of topics of interest to consumers that had been scheduled for February 3 and 4.
- Advisory Committee Portal Launched - FDA launched a new online, interactive portal that allows for electronic submissions for persons interested in sitting on one of the agency’s 33 advisory committees. The portal provides a paperless means of applying and applications will be uniform and streamlined. The announcement states that nominations may be made by professional societies, industry and consumer groups and other interested persons. Coincident with the launch of the portal, the agency also made available conflict of interest guidelines.
- FDA Bars Specific Ranbaxy Facility from Producing Drugs for U.S. Market – FDA announced that it was extending the scope of an existing consent decree with Ranbaxy Laboratories to cover pharmaceutical ingredients from a Toansa, India facility which would prohibit the distribution, manufacture, exportation or provision of API to American companies following an inspection of the facility on January 11 of this year where numerous violations were said to have been found.
Yee hah – let’s get on with the weekend. Marky (the cow) and me (Marky the person) wish you a very good one.
Photo courtesy of Anne Becker.
Two full weeks back in the saddle and I’m ready for a three day weekend. I’m late today with the Weekly Roundup, and there isn’t a lot of news to digest, but here are a few things that came out of this week that caught my eye.
- IOM Releases Report on Caffeine in Food and Supplements – Following a public workshop held in August, 2013 on the topic, the Institute of Medicine released a report today on caffeine in foods and supplements - a workshop which FDA requested. The report embodies what is known about the regulation and science related to caffeine in foods and supplements including intake and exposure to caffeine, safety signals and surveillance, exploring exposure levels for vulnerable populations and effects on the cardiovascular and central nervous systems. The report can be read online for free.
- Test to Diagnose Developmental Disabilities – FDA announced approval of the first-of-its-kind post-natal test to help diagnose developmental delays and intellectual disabilities in children. The test uses a blood sample to analyze the entire genome at one time, detecting large and small chromosomal changes. The press release from FDA states that the test should not be used as a stand-alone diagnostic test nor should it be used in any other circumstance.
That’s it for me this week. For those of you wondering, as I have been – Daylight Savings begins March 9. If you can’t tell it, I am counting the days. Here in the US it is a three-day weekend. I hope you all enjoy it.
My thanks to Anne Becker for the photo.