neptune22222, to opensource

Open source artificial pancreas software has gotten FDA approval! And open source hardware solutions are coming!

https://www.nature.com/articles/d41586-023-02648-9

GottaLaff, (edited ) to random
@GottaLaff@mastodon.social avatar

YES! 💉😷 “#FDA gave the green light to updated #Covid-19 #vaccine booster shots from #Moderna and #Pfizer/BioNTech. The updated vaccines are each approved for people 12 and older and are authorized under emergency use for individuals 6 months through 11 years old. As part of the FDA’s update, the original bivalent Moderna and Pfizer-BioNTech Covid-19 vaccines are no longer authorized for use in the US” 1/...

https://www.cnn.com/2023/09/11/health/fda-signs-off-on-updated-covid-19-vaccines

GottaLaff, to random
@GottaLaff@mastodon.social avatar

⚠️ warns consumers against using 26 eye drop products because of infection risk

https://www.cbsnews.com/news/eye-drop-recall-fda-cvs-health-rite-aid-target/

w7voa, to random
@w7voa@journa.host avatar

approves a birth control pill to be sold without a prescription for the first time in the US. https://www.fda.gov/news-events/press-announcements/fda-approves-first-nonprescription-daily-oral-contraceptive

ProPublica, to Health
@ProPublica@newsie.social avatar

Millions of People Used Tainted Breathing Machines. The Failed to Use Its Power to Protect Them.

The FDA’s complaint-tracking system for medical devices allowed Philips to obscure when it knew about dangerous CPAPs.

New reporting shows the regulatory lapses extend to many devices and companies.

https://www.propublica.org/article/how-the-fda-failed-to-protect-millions-of-people-tainted-breathing-machines?utm_medium=social&utm_source=mastodon&utm_campaign=mastodon-post

GottaLaff, to random
@GottaLaff@mastodon.social avatar

⚠️ “ advisory panel declared an ingredient in widely used oral doesn’t work, setting the stage for dozens of products to be removed from U.S. store shelves.

At issue is phenylephrine, an almost-century-old ingredient in versions of Benadryl, Mucinex, Tylenol and other over-the-counter pills, syrups and liquids to clear up congested noses.”

Nonya_Bidniss, to random
@Nonya_Bidniss@mas.to avatar

Attributed to someone on FB.

paul, to Health
@paul@oldfriends.live avatar

FDA approves nonprofit's over-the-counter opioid overdose nasal spray used to reverse opioid overdose

RiVive, made by Harm Reduction Therapeutics, is the second product the FDA has approved.

But unlike other opioid overdose products, the 3 milligram treatment will be available for free or low cost, and its sales will bring no profit to its manufacturer

🔗 https://www.wcpo.com/fda-approves-nonprofit-s-over-the-counter-opioid-overdose-nasal-spray

GottaLaff, to Health
@GottaLaff@mastodon.social avatar

#FDA has approved blood test that can identify pregnant women who are at imminent risk of developing a severe form of high blood pressure called pre-eclampsia, a leading cause of disability and death among childbearing women.

The condition disproportionately affects Black women in the United States…”
#health #WomensHealth

https://www.nytimes.com/2023/07/03/health/pregnancy-preeclampsia-test.html?smid=nytcore-ios-share&referringSource=articleShare

Don’t use pregnancy tests linked to illegal California lab, FDA warns (arstechnica.com)

The Food and Drug Administration is warning consumers not to use any at-home tests made by Universal Meditech, Inc. (UMI), the company behind an illegal medical lab hidden in a warehouse in the small city of Reedley, California. The lab was shut down earlier this year by local, state, and federal agencies, which are still...

jsrailton, to random
@jsrailton@mastodon.social avatar

Countdown Florida trying to pass a law absolving of responsibility for sudden death.

bicmay, to random
@bicmay@med-mastodon.com avatar

"A scientific paper that raised concerns about the safety of the abortion pill mifepristone was retracted by its publisher this week. The study was cited three times by a federal judge who ruled against mifepristone last spring. That case, which could limit access to mifepristone throughout the country, will soon be heard in the Supreme Court."

https://www.npr.org/sections/health-shots/2024/02/09/1230175305/abortion-pill-mifepristone-retraction-supreme-court

#healthcare #reproductivejustice #pregnancy #prescriptiondrugs #fda #mifepristone #abortion

KimPerales, to random
@KimPerales@toad.social avatar

Cereals are harming Americans' health bc CEOs allowed toxic chemicals to taint their products. General Mills, PepsiCo, other food brands, & the growers are responsible for the harmful chem.

A pesticide linked to infertility in animals is showing up in the majority of oat-based foods sold in the US, incl. Quaker Oats & Cheerios. Chlormequat, was detected in samples taken from 2017-23, with levels increasing in the most recent years.

https://www.cbsnews.com/news/cheerios-quaker-oats-infertility-chemicals-in-cereal-ewg/?ftag=CNM-00-10aab7e&linkId=325938817

BruceMirken, to random
@BruceMirken@mas.to avatar

Smart medical folks I know said 3 years ago that the 's conditional approval of , an expensive drug of dubious value for , was a mistake. They were right. https://www.nbcnews.com/health/health-news/biogen-stop-alzheimers-drug-aduhelm-rcna136619

GottaLaff, to random
@GottaLaff@mastodon.social avatar

👀 approves groundbreaking treatment for advanced melanoma

TIL therapy shrank tumors in about a third of patients who had run out of treatment options, according to a clinical trial.
https://www.nbcnews.com/health/health-news/fda-approves-groundbreaking-treatment-advanced-melanoma-rcna138005

faraiwe, to random

@US_FDA is about to authorize the variant (BA.2.86) booster shot, next week.

@CDCgov is pondering whether to RESTRICT booster to some ages, 75+ initially.

You CAN tell them NOT to have their head shoved up their ass, and allow EVERYONE to take it by voicing your opinion, here.

https://www.regulations.gov/document/CDC-2023-0060-0001

YES, it DOES make a difference. Enough people honk at them, they WILL do the right thing. And ONLY then will they do the right thing.

Brad_Rosenheim, to random

Make it make sense. On one hand, when it comes to medications that chemically induce early term , we are not supposed to take them because the didn't test them enough. But on the other hand, we have this. We cannot bar doctors for prescribing for COVID because it was never tested on that virus at all.

https://mastodon.tucsonsentinel.com/@TucsonSentinel/111008107209947816

sbseltzer, to random

The comments people are leaving for the regarding are absolutely heartbreaking
https://www.regulations.gov/document/FDA-2023-N-0363-0001

Deadline for comments is June 26th. If you know of anyone who has Long COVID please pass this along to them or to someone who cares for them. We need to make our government organizations see how urgent it is to start developing treatments for this.

You can view a recording of the public meeting here: https://fda.yorkcast.com/webcast/Play/4eba453a2412474e98fff1fabcc63ac51d

GottaLaff, to random
@GottaLaff@mastodon.social avatar

An advisory panel found that the benefits of making a available over the counter outweighed the risks. The agency is expected to decide this summer whether to allow nonprescription sales of an oral contraceptive

https://breaking.iavian.net/article/336359

bicmay, to random
@bicmay@med-mastodon.com avatar

"The investigation has found that most medical devices, including many implants, are now cleared for sale by the FDA without tests for safety or effectiveness. Instead, manufacturers must simply show they have “substantial equivalence” to a product already in the marketplace — an approval process some experts view as vastly overused and fraught with risks."

https://kffhealthnews.org/news/article/medical-device-malfunction-fda-oversight-patient-harm/

bicmay, to random
@bicmay@med-mastodon.com avatar

"Sidney M. Wolfe, a doctor turned consumer activist who battled drug companies, lobbyists and regulators during a nearly five-decade crusade against ineffective, risky and overpriced medications that made him a hero to patient advocacy groups and an implacable foe to anyone who opposed him, died Jan. 1 at his home in Washington. He was 86."

https://www.washingtonpost.com/obituaries/2024/01/01/sidney-wolfe-public-citizen-dies/?_hsmi=288467802&_hsenc=p2ANqtz---4iL8UCXOz6OAn4cmzgOahO8qp_foLLwW2ZexD1FmZw2kqGVb_3uMJnRfpo7VeUzHyTPsS0q74RUx2AUaTfEzZqdQqA

#obituary #publiccitizen #fda #prescriptiondrugs #phrma

BenjaminHCCarr, to random
@BenjaminHCCarr@hachyderm.io avatar

#US verges on #vaccination tipping point, faces thousands of needless deaths: #FDA
Top regulatory officials call for clinicians to speak up and drown out #misinformation.
Data from #CDC last year found that, for the third consecutive year, vaccination rates among #kindergartners had continued to slip, with rates of non-medical vaccination exemptions rising to an all-time high. 10 states with vaccination exemption rates over 5 percent!
https://arstechnica.com/science/2024/01/anti-vaccine-nonsense-will-likely-kill-thousands-this-season-fda-officials-say/ #RSV #Flu #COVID #Measles #Influenza

ProPublica, to news
@ProPublica@newsie.social avatar

Repeatedly Rejected Claims About Philips Breathing Machines, Emails Show

As Philips reassured patients that millions of recalled machines were safe, internal emails show federal regulators privately told the company its testing didn’t account for the impact of long-term harm from tainted devices.

https://www.propublica.org/article/fda-repeatedly-rejected-safety-claims-philips-breathing-machines-emails-show?utm_medium=social&utm_source=mastodon&utm_campaign=mastodon-post

w7voa, to random
@w7voa@journa.host avatar
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