It is hot. Hot. Hot. Hot. Eggs are frying on sidewalks everywhere.
And if you were completely distracted by that fact this week, here is a little bit of what happened in our world:
- Pfizer Conducts Virtual Clinical Trial – In what was an inevitable development and from the book of “why hasn’t someone already done this” this week Pfizer announced that they would be conducting the first “virtual” clinical trial. According to the press release – “The Research on Electronic Monitoring of OAB Treatment Experience – REMOTE – is a U.S.-based Participatory Patient-Centered (PPC) clinical trial designed to assess the safety and efficacy of Detrol LA (tolterodine tartrate), a treatment for overactive bladder (OAB). Pfizer and its research partners hope to determine whether the results of the pilot REMOTE “virtual trial” can replicate the results of a previously completed Phase IV Detrol LA trial, and in this way begin to validate virtual, patient-centered approaches to clinical research.” The innovative effort even got a thumbs up from FDA in the form of a favorable comment about the trial from Dr. Janet Woodcock in an article in the Pharma Times. Given the potential for cost savings, one wonders if others will soon follow.
- FDA Issues Draft Guidance on Nanotechnology – Nano Nano, said Robin Williams as Mork from Ork. But his is a different Nano. This week the FDA took its “first step” in the regulation of nanotechnology with the release of a draft guidance on the topic. However, unlike most guidances, this one seems to be trying to begin to even define the environment. Said the release, specifically, the agency named certain characteristics – such as the size of nanomaterials used and the exhibited properties of those materials – that may be considered when attempting to identify applications of nanotechnology in regulated products. “With this guidance, we are not announcing a regulatory definition of nanotechnology,” said Margaret A. Hamburg, MD, Commissioner of Food and Drugs. “However, as a first step, we want to narrow the discussion to these points and work with industry to determine if this focus is an appropriate starting place.”
- Europe Has Big E. Coli Outbreak – One Starts in Tennessee – Everyone who reads a newspaper, watches news or goes online to keep up to date has heard about the huge E.Coli outbreak in Europe, but it was only this morning that I heard of a very small one occurring in Tennessee. And in reading about it, I discovered a nifty blog that just covers E.Coli. And in the spirit of this, here is a vid the FDA put up on washing your fruits and vegetables correctly.
That’s it for me this week. Short and sweet. Have a good weekend everyone.