Oh dear. I originally dated this Weekly Roundup as being in 2011. That is the kind of week it has been – I’m not even sure what year it is. The time of year, however, is obvious, with multi-tinted leaves fluttering in sunlight, shorter days, and cooler temperatures and we all are thinking about Thanksgiving recipes. Well, I am, anyway, even if in 2011.
Meanwhile, here is a bit of what happened this week:
- Trans Fats Action by FDA – FDA announced yesterday that it was taking action in relation to foods containing Trans Fats. Noting that if industrially produced trans fat were eliminated from foots, it might be possible to prevent 20,000 heart attacks and 7000 heart-related deaths each year, FDA announced its “preliminary determination” that partially hydrogenated oils (PHOs) are no longer to be considered”generally recognized as safe” for use in foods. The agency said that it opened up a 60-day comment period to collect input regarding the GRAS status pre-determination. Over the past few decades, consumption of PHOs has diminished considerably, it still exists in many prepared foods. If, ultimately, it is determined that PHOs should no longer be used in foods, FDA said that it will give a timeline for industry to comply. The agency issued a press release on the topic as well as a blog posting on its blog FDA Voice. The agency also took the unusual step of sending out an email to a list asking that the information be tweeted, however, by that time, the news had already saturated Twitter.
- New Guidance on Devices – FDA announced availability of a new guidance entitled “Design Considerations for Pivotal Clinical Investigations for Medical Devices” which is meant to offer guidance for the design of clinical studies intended to support new premarket submissions. It describes different study design principles for medical device studies.
- FDA Seeking Comment on New Generic Rule on Information Updates – FDA announced today that it would be seeking public comment on a rule that would allow generic drug makers to use the same process as brand drug manufacturers to update safety information in the product labeling. “Under the proposal, generic drug manufacturers would be able to independently update product labeling (also called prescribing information or package inserts) with newly-acquired safety information before the FDA’s review of the change, in the same way brand drug manufacturers do today.” In addition, generic manufacturers would have to inform the brand name manufacturer about the change. Full information and background is available in the Federal Register posting on the topic.
That’s it for me this week folks. Have a wonderful and restful weekend.