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.