NLR:
Over the course of 2020, the Food and Drug Administration (FDA) released numerous guidance documents covering diverse areas and aimed at increasing the availability of various medical products to prevent, treat, and diagnose COVID-19. Some of our prior blog posts on those pandemic response activities implemented by FDA can be found here and here. In all of those actions, FDA made clear that the agency’s enforcement discretion policy was temporary, or that an emergency use authorization (EUA) was being granted pursuant to statutory criteria that include a requirement that there be “no adequate, approved, and available alternative to the product,” which by definition renders the EUA temporary, as well. Accordingly, several EUAs granted to diagnostic tests, therapeutic products, and medical devices have been revoked based on a determination that all of the criteria necessary to support emergency authorization under the statute can no longer be met. And although the public health emergency is not over even as 2021 comes to a close, FDA has kept its promise to continually reassess circumstances and needs on the ground in the United States and to modify policies and emergency authorizations as necessary.
Notably, early on in the pandemic FDA’s Center for Drug Evaluation and Research (CDER) developed and released multiple enforcement discretion policies intended to increase the supply of alcohol-based hand sanitizer by, in part, allowing non-traditional manufacturers to produce these non-prescription drug products. In mid-October 2021, the agency announced via a statement by the CDER Director that “the supply of alcohol-based hand sanitizer from traditional suppliers has increased, and now, most consumers and healthcare personnel are no longer having difficulty obtaining these products. Therefore…it’s appropriate to withdraw the temporary guidances and [we] are providing manufacturers time to adjust their business plans related to production of these products under these temporary policies.” (A Federal Register notice announcing the withdrawal of those enforcement discretion policies was also published and is available for review here.) It’s also worth pointing out that CDER has identified a significant amount of serious adulteration in alcohol-based hand sanitizers over the past year or so, leading to many recalls and import alerts, which almost certainly contributed to this regulatory decision as well. more
I hope their action starts a Gvnt Bureaucracy Freny to ´OUT ROLL-BACK´
OR
Claims of ´I ROLLED BACK THE MOST 1st´ by the dozens
………….or even a gvt FRENZY
BRING BAKC EDIT
“And although the public health emergency is not over even as 2021 comes to a close…”
The gov do love their emergencies. But everything I’ve seen in the surrounding four or five counties (NW Ga) for the duration doesn’t even rise to the level of kerfluffel.
If the media hadn’t been in full throated panic scream mode we’d probably think a nasty flu had just blown through.
There never was an emergency. Thanks trump, you effing snake.
I don’t see many mask wearers or Karens around here, but I did see one today in a public bathroom. She was a cow, had her mask on, washed her hands and timed it on her wrist watch, kept glaring at me like I was going to kill her. I was thinking I bet you got your jab and when she really glared I realized oops I said that out loud, I hope she doesn’t sit on me. lol
She just glared, grabbed her paper towel dried her hands, rubbed on her little bottle of hand sanitizer she had in her pocket, grabbed another paper towel and turned off the water with it. Opened the door with it.
Then my husband who was waiting on me asked me if I saw the cow in a mask, I relayed my story and he said she wasn’t done with her hand sanitizer and was rubbing it on her hands all the way to the exit door which she used her fat ass to open and rubbed more of it on her hands after she got outside.