In a move that's sure to be watched closely by medical regulators worldwide, America's Food & Drug Administration (FDA) has issued its final regulatory guidance on regulating medical apps running on smartphones. The announcement formalises a draft guidance issued in July, the culmination of a long process under which 100 apps …
I wonder if the FDA 'Apps Branch' will be as open to lobbying and manipulation as the food and drug divisions? There's a new opportunity for someone if you've got unrealized lobbyist dreams and have found all the traditional opportunities too crowded and competitive.
I'm sure there's some reason for concern in all this, but I'm not convinced it is apps. I just can't help but feel the same agency that keeps safe, effective and affordable drugs, used by billions of people (outside the US), out of the hands of the public, on behalf of the pharma industry, doesn't another responsibility. They seem awfully busy already.
They bitch all the time they don't have staff or resources to do more reviews of drugs already approved in other civilized countries and that there aren't enough food safety inspectors. Instead of nosing into another realm, this seems like a good opportunity to step up fulfillment of their original mandate.
Practicing medicine without a license has been illegal for a LONG time. Frankly, I'm surprised it's taken the FDA this long to notice this category of
Hopefully this new process won't take resources away from conventional medical device review, which seems to be slipping recently. Of course, if TPTB really wanted to improve access to medical equipment and pharmaceuticals without reducing patient safety, they wouldn't insist on separate FDA facility approvals for plants that have already been approved by the EU... oh, wait, we'd get rid of all those medicine shortages. Can't have that, now, can we?
I wasn't sure whether the facepalm or the mushroom cloud was more appropriate, but had to pick one or the other.
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