djjose
Joined 16 years ago
Joined 16 years ago
src: http://searchengineland.com/yahoo-boss-moves-from-yahoos-ind...
src2: I worked on the Yahoo Search team at the time of the deal.
I too believe that mobile web will one day overtake mobile native apps for most peoples' daily usage. I just don't think it'll look or act anything like what we're currently doing. Luke Wroblewski gives a great talk about the early days of a new medium being an awkward state where we try to shoehorn what worked in the last medium into it. At some point we'll figure out a design and usage patten for the mobile web that'll make a world of sense in hindsight. We're just not there yet IMO and of course I have no idea what this looks like.
The FDA, while being a pain in the rear at times, will actually work with you to meet compliance. But you have to show work and be continually in touch with them and show progress (and document everything according to your own procedures, complying to regulations of course). You can't just say you're working on compliance and then not follow through and show evidence. The issue for 23andMe is the on-label use of the product "in the diagnosis of disease or other conditions or in the cure, mitigation, treatment, or prevention of disease, or is intended to affect the structure or function of the body." They market the product this way. If you want to market your product as such, you have to show proof to the FDA and receive approval to label the medical product in this manner. It looks like 23andMe is either not working towards compliance (and is misleading the FDA) or is doing a terrible job documenting their work towards compliance and keeping the FDA abreast (my guess is this is what's happening). That in itself will get you in trouble, but then expanding your marketing for even more on-label use of the product - which hasn't been submitted to the FDA apparently - while at the same time not having FDA approval for the original use is just plain stupid.