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 been no postings between the last Weekly Roundup and this one and for that I am sorry. Sometimes life just speeds up. Here are a few things I did note in passing however:
- FDA Gears Up Around Regulation of Cell and Tissue Products – This week FDA announced that it would be (1) extending the comment period around several guidance documents related to the regulation of Human Cell and Tissue Based Products and (2) Holding a Public Workshop on September 8 entitled “Scientific Evidence in the Development of Human Cells, Tissues, and Cellular and Tissue-Based Products Subject to Pre-Market Approval“, and (3) scheduling a two-day meeting for September 12-13 to get input on the guidance documents.
- FDA Biosimilars Page – In the wake of the second approval of a biosimilar (covered a few weeks ago in EyeonFDA), the agency has been gearing up to educate stakeholders about the category. Currently on the landing page of the FDA website carousel is a link that takes you to a page entitled “Biosimilars: More Treatment Options Are on the Way“. The page contains an overview of the most recent approval, a resource to sign up for updates, and also links to learning more about biosimilars. One of the links is to a page entitled “FDA 101: Regulating Biological Products“, including a delineation between CDER and CBER overview, but no mention of the naming issue regarding biosimilars and it appears the page has not been updated for a long time. So more organization around education of biologics given a new potential era of biosimilars, but the material is some old/some new.
- Agency Launches Smokeless Tobacco Campaign – FDA announced this week an expansion of a campaign called “The Real Cost” in 35 markets aimed at white, rural youth to carry warnings about the consequences of smokeless tobacco use, highlighting risks of gum disease, tooth loss and oral cancer. The campaign is integrating its approach including paid traditional media approaches as well as a social/digital effort. The campaign is part of a broader effort to educate at risk youth on tobacco use.
That’s it for me this busy week. I hope things slow down a bit. And by all means, have a good weekend.