4 ms·

Oof, Rutgers miswrote the entire article. Flagged for being extremely misleading on Rutgers' part (OP only quoted them). This isn't an approval, it's an Emerge

Oof, Rutgers miswrote the entire article. Flagged for being extremely misleading on Rutgers' part (OP only quoted them). This isn't an approval, it's an Emergency Use Authorization. They're completely different. https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization https://www.fda.gov/emergency-preparedness-and-response/mcm-... An EUA is specifically to permit unapproved uses in exigent circumstances only. Approval still requires the full workup: https://www.fda.gov/news-events/approvals-fda-regulated-products/about-fda-product-approval https://www.fda.gov/news-events/approvals-fda-regulated-prod... --- @dang, is there value in changing the title from its current state ("FDA Grants Approval for First Saliva Based Coronavirus Test") to "FDA grants Emergency Use Authorization for Saliva Based Coronavirus Test"? --- Edit 2:33pm EDT: calling Rutgers to clarify. Edit 2:36pm EDT: the appropriate contact for the article has received my message and (as best as I know) is clarifying the release. Edit 3:01pm EDT: thanks for changing the title, dang!

ceejayoz 7y ago
Is it misleading, or are they just using lay terminology in a press release aimed at lay people? They were approved to begin emergency use without the usual steps to "FDA approval", correct?
- usrusr 7y ago
  Easy english could be a reasonable excuse if the precise terminology would be indecipherable to laypersons, but I don't see that here. "FDA grants emergency use authorization [...]" would give the exactly same diffuse "they allowed something on some level" information to people like me who are unaware of the specifics, but without ruining it for those in the know.
  - ceejayoz 7y ago
    I mean, the subheadline is, in large bold text: > Emergency use authorization granted for new biomaterial collection approach They're not hiding anything here, as far as I can tell.
- IdoRA 7y ago
  They are using lay terminology, but it doesn’t matter for regulatory affairs: authorization, approval, and clearance are legally distinct and companies are fined for using the wrong word.
catalogia 7y ago
This seems to be a very specialized use of the term 'approval.'
deleted 7y ago
[deleted]
asn0 7y ago
YES, please correct the title! Per an AP article[1] on the confusion surrounding this issue: > Companies are supposed to state that their tests have not been FDA-approved and cannot rule out whether someone is currently infected. I see no language like that in the article. But lots of quotes implying efficacy of the test: > we no longer have to put health care professionals at risk for infection > we can preserve precious personal protective equipment > we can significantly increase the number of people tested each and every day Sadly, I think we are about to see more of this, as companies jump at the chance to get some PR and stock price bump. [1] https://www.sltrib.com/news/2020/04/12/fears-wild-west-covid/ https://www.sltrib.com/news/2020/04/12/fears-wild-west-covid...
dang 7y ago
Sure. We've changed the title above.
- eganist 7y ago
  Appreciate the rapid response here. Thanks!

ceejayoz 7y ago

Is it misleading, or are they just using lay terminology in a press release aimed at lay people? They were approved to begin emergency use without the usual steps to "FDA approval", correct?

usrusr 7y ago
Easy english could be a reasonable excuse if the precise terminology would be indecipherable to laypersons, but I don't see that here. "FDA grants emergency use authorization [...]" would give the exactly same diffuse "they allowed something on some level" information to people like me who are unaware of the specifics, but without ruining it for those in the know.
- ceejayoz 7y ago
  I mean, the subheadline is, in large bold text: > Emergency use authorization granted for new biomaterial collection approach They're not hiding anything here, as far as I can tell.
IdoRA 7y ago
They are using lay terminology, but it doesn’t matter for regulatory affairs: authorization, approval, and clearance are legally distinct and companies are fined for using the wrong word.

catalogia 7y ago

This seems to be a very specialized use of the term 'approval.'

deleted 7y ago

[deleted]

asn0 7y ago

YES, please correct the title! Per an AP article[1] on the confusion surrounding this issue: > Companies are supposed to state that their tests have not been FDA-approved and cannot rule out whether someone is currently infected. I see no language like that in the article. But lots of quotes implying efficacy of the test: > we no longer have to put health care professionals at risk for infection > we can preserve precious personal protective equipment > we can significantly increase the number of people tested each and every day Sadly, I think we are about to see more of this, as companies jump at the chance to get some PR and stock price bump. [1] https://www.sltrib.com/news/2020/04/12/fears-wild-west-covid/ https://www.sltrib.com/news/2020/04/12/fears-wild-west-covid...

dang 7y ago

Sure. We've changed the title above.

eganist 7y ago
Appreciate the rapid response here. Thanks!