Hacker Read

i_am_nomad · 2018-11-20 17:54:02+00:00

This looks like it might need FDA approval.

nitrogen | karma 22058 | avg karma 2.02 · | 2017-11-13 19:49:10

Require it for FDA approval

dev_tty01 | karma 4663 | avg karma 4.24 · | 2022-06-08 10:10:52

Wow. Hate to imagine the FDA approval process for this.

rasz_pl | karma 1849 | avg karma 0.86 · | 2015-07-18 16:55:46+00:00

Sounds like FDA approval process.

heavyset_go | karma 25689 | avg karma 3.63 · | 2020-02-05 20:49:28

Surely this is a claim that warrants FDA approval.

pm90 | karma 12562 | avg karma 2.33 · | 2015-10-14 22:14:38

That's probably the reason why the FDA wants them to get approval before making such evaluations.

AnIdiotOnTheNet | karma 21390 | avg karma 2.72 · | 2019-08-29 19:51:15

It is difficult to imagine what would be marketed over the internet like this that requires FDA approval and isn't at least a bit slimy. If there's something obvious thing that fits in that category that isn't, no one has mentioned it yet.

xirdstl | karma 866 | avg karma 3.42 · | 2015-10-22 05:08:32+00:00

Not speaking to the price, this makes sense. To achieve FDA approval, their reporting is much more conservative. That's probably for the best.

jasonjmcghee | karma 2166 | avg karma 2.88 · | 2024-04-10 04:23:40

This sounds so cool and great, but no mention of FDA approval anywhere.

Sounds like it's being sold as "cosmetic".

It changes my body chemistry. It gets described as a vaccine.

Not sure humans should be the test subjects and very concerned anyone can just buy this.

And I know people will. I want to and am having to exert will to use my better judgement.

In the safety section, it makes it clear it can't be reversed without serious effort and no evidence anyone has successfully reversed it.

reply

aphextron | karma 13989 | avg karma 5.79 · | 2018-10-28 20:27:51+00:00

Does this have regulatory approval already?

streety | karma 430 | avg karma 1.17 · | 2008-10-24 09:43:44

Does it have FDA approval?

dragonwriter | karma 118260 | avg karma 2.17 · | 2013-11-25 16:05:58+00:00

If they get an FDA approval, it would mean that there has been review that their outputs are actually appropriate. That's why the FDA is required by law to review items marketed for diagnosing disease.

maxerickson | karma 36996 | avg karma 2.02 · | 2016-04-28 16:33:39

It says in the article that it is pending a regulatory review.

tsimionescu | karma 17553 | avg karma 2.17 · | 2021-07-10 21:58:03

FDA approval is needed to seek something as medication. If they want to package it as a supplement, they can sell it today.

notyourwork | karma 4361 | avg karma 2.32 · | 2017-07-28 20:03:04+00:00

Is this something that is in scope for FDA?

MaysonL | karma 18139 | avg karma 3.93 · | 2014-06-26 18:39:31

Note however that they are applying for FDA approval of all their proprietary tests.

defap | karma 376 | avg karma 8.95 · | 2017-09-21 17:26:59+00:00

They have FDA approval. It’s stated in the first paragraph of the article.

ceejayoz | karma 74610 | avg karma 3.33 · | 2024-04-01 20:23:11

Such things are already highly likely to fall under the FDA’s purview.

tim333 | karma 15551 | avg karma 1.53 · | 2020-10-31 16:57:24+00:00

The FDA probably won't approve anything for ages but you could put the app out anyway?

refurb | karma 27208 | avg karma 1.53 · | 2018-10-26 00:45:18+00:00

My question was more song the lines - “is this rigorous enough for FDA approval”?