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#emergency use authorization
instaviewpoint · 22 days
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COVID State of Emergency by the FDA
COVID State of Emergency by the FDA April 7 2024By PK Morgan Perhaps, in my previous article that contains a section on Emergency Use Authorization (EUA), I was a bit too vague or we are accustomed to taking everything our government dishes out regardless of legality. An EUA was issued for COVID tests on April 5 2024. Why has the FDA approved a COVID/Flu self test in April of 2024 with…
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rodspurethoughts · 1 year
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FDA Simplifies Use of Bivalent mRNA COVID-19 Vaccines for All Doses Administered to Individuals 6 Months and Older
The U.S. Food and Drug Administration (FDA) has amended the emergency use authorizations (EUAs) of the Moderna and Pfizer-BioNTech COVID-19 bivalent mRNA vaccines to simplify the vaccination schedule for most individuals. This includes authorizing the current bivalent vaccines (original and omicron BA.4/BA.5 strains) to be used for all doses administered to individuals 6 months of age and older,…
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didanawisgi · 2 years
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cancerabcs · 2 years
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What is Evushield and who should consider taking it?
We have received a few questions from some of our readers asking about a yet unapproved drug called Evushield (Tixagevimab co-administered with Cilavimab).  It seems that some doctors have prescribed Evushield under the FDA’s Emergency Use Authorization Program.
 What is Evushield, and who should consider taking it?
 In December of 2021, the U.S. Food and Drug Administration (FDA) issued an emergency use authorization for AstraZeneca’s Evushield (tixagevimab co-packaged with Cilavimab and administered together).  Evushield is designed to be used for the pre-exposure prophylaxis (prevention) of COVID-19 in certain adults and pediatric individuals (12 years of age and older weighing at least 40 kilograms [about 88 pounds]) who are severely immuno-compromised or unable to take a COVID-19 vaccination. 
The product is only authorized for those individuals who are not currently infected with the SARS-CoV-2 virus and who have not recently been exposed to an individual infected with SARS-CoV-2. The authorization also requires that individuals either have: 
moderate to severely compromised immune systems due to a medical condition or due to taking immunosuppressive medications or treatments and may not mount an adequate immune response to COVID-19 vaccination (examples of such medical conditions or treatments can be found in the fact sheet for health care providers) or;
a history of severe adverse reactions to a COVID-19 vaccine and/or component(s) of those vaccines, therefore vaccination with an available COVID-19 vaccine, according to the approved or authorized schedule, is not recommended.
 At Cancer ABCs, we have spoken with a few patients who have taken Evushield and they have consistently reported that the drug combination has not added any additional side effects to their treatment protocols.
 Please don’t think that Evushield is a substitute for COVID-19 vaccinations, it is not.  If you qualify for Evushield you should also be vaccinated and boosted.
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meeraoperon · 2 years
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Get prepared for Post Emergency Use of Authorization
Emergency Use of Authorization (EUA) overview: 
EUA i.e. Emergency use Authorization is a tool. Medical devices or products are authorized for use under specific circumstances. FDA makes use of this (EUA) on a temporary basis to fulfil urgent medical needs during public health emergencies. EUA is a pathway; it is not the approval or clearance for the product; it simply an authorization for public health for the duration of emergencies. The starting place of EUA lies normally in the pharmaceutical and biotechnological area.
FDA’s Guidance on EUA:
On February 22,2022 the united states FDA hosted a webinar approximately the draft guidance on COVID-19 transition plans for medical devices. due to pandemic the deliver chain is disrupted, as demand for sure devices exceeds deliver. To guard public health FDA has issued emergency use authorization for greater than 800 medical devices such as COVID-19 checks and PPE.
FDA Draft guidance for medical devices Prepares for end of Pandemic, The FDA EUA guidance is set giving medical device manufacturers a yr’s notification previous to finishing disaster to apply approvals submit-pandemic. whilst the modern-day pandemic response stays the FDA’s pinnacle priority, to provide readability to all manufacturers, the FDA issued two draft steering files to provide hints to producers which can or won't want to preserve to distribute medical devices after the relevant EUA assertion is terminated.
Read More - Emergency use Authorization
Read More Article - 
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v-v-jones · 9 months
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loxare · 3 months
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A game I've been playing in early access for the past half year, Immortal Life, came out fully wednesday, and I love it so much and think that everyone should play it. Anyways I wrote a thing
Mu Xia hummed as she carefully placed the plate of dumplings in her basket. They were a new recipe, pork and chive, and she really hoped her shijie liked them.
Carefully balancing her basket on her arm, pushing aside the kitchen curtain with the ease of long practice, she nearly dropped everything when Ji Yaohua’s voice called out, “Mu-shimei! I was just speaking to your mother about importing things for the inn. She told me to ask you about anything you needed for the kitchen.”
Basket balanced once again, Mu Xia smiled. “Oh course, Ji-shijie, thank you. It will be our usual list, but could you see if you can get more of the chives? If these turn out, I think they’ll be a hit with the customers.”
Yaohua leaned in, curious. “What are they? They smell good.”
“Pork and chive dumplings! I have some extra in the back if you want, but these are for Shijie!” In this context, there could only be one Shijie. The farmer of the Misty Valley was the reason she was even a part of Guiyun Sect after all.
Li Mengqing appeared from around the corner, summoned by the call of a new food to try. “I’ll get them! Just on the serving table?” Not waiting for an answer, she slipped into the kitchen.
“What’s the occasion?” Yaohua’s eyes narrowed slightly. “If it’s her birthday you have to tell me. She refuses to say.”
That sounded like Shijie. “No, not at all. I just haven’t seen her in a few days, so I wanted to check on her and make sure she was eating well.”
A strange look crossed Yaohua’s face. It looked pained, but also glum and mischievous for some reason. “I see. I think she’ll enjoy those a lot. Say hi for me.”
“I will!” Ji Yaohua’s strange moods wouldn’t deter Mu Xia. “See you later Ji-shijie, Li-shimei!”
After Mu Xia was gone, Mengqing came out and passed Yaohua a dumpling. “Ji-shijie. If Shijie hasn’t been seen in a few days...”
“Yes.” Yaohua took a bite of the dumpling. It was very good indeed. She’d have to research where to obtain chive seeds. The Misty Valley could support nearly any kind of plant in its soil, so it was just a matter of sourcing. And having Shijie grow them would be much cheaper in the long run than importing chives. As for Mu Xia... “She’d have to find out sometime. Besides, if it’s been a few days, Shijie could probably use the food.”
“Hm. True.” Mengqing ate another dumpling. “Hey, do you think it’s possible to make a red bean dumpling?”
She’d never had a sweet dumpling before. “I’m sure you can convince Mu-shimei to try.”
The walk to the Misty Valley was pleasant. The weather was warm, and a bit breezy. There was rain on the horizon, but it wouldn’t hit until tonight. She spoke briefly to Zhou Qian’er about the day’s catch, and to Chen Yuanzhou about fishing her up a few puffer fish for an upcoming banquet.
The Misty Valley hummed with power as it always did. She could almost see the crops growing as they absorbed the spiritual energy, cycling it and sending it back into the earth, stronger. That was one of the things that had surprised her, after she’d started cultivating. Mu Xia had been to the Misty Valley before, usually on her way to the Sunset Forest to pick scarlet sage, but never before had she been able to see the energy she had always felt in the place. It had always felt alive to her, vibrant in ways that she hadn’t been able to comprehend. It was no wonder that Shijie was so strong, if this was where she lived, worked, cultivated.
Speaking of. “Shijie? Are you here?” She checked both fields, poked her head into the Blessed Land, knocked on the door of the freshly renovated house. But she was nowhere to be seen.
Then, suddenly, a flash of light. The same as the others when they teleported somewhere else. Mu Xia couldn’t wait to learn that technique. “Shijie, you’re home! I brought- ” She stopped short.
It... was Shijie. She could tell. But the usual flowing robes and perfectly styled hair were in horrible disarray, and covered in... substances. Mud was the least egregious of the substances, but Mu Xia could also see some sort of green-grey plant sap that smelled horrible, more green goop, and blood (?!) in various shades and consistencies. “Shijie?!”
Instead of asking for help or something, Shijie wobbled and mumbled, “whatimezit?”
“I...” Mu Xia checked the position of the sun. “Almost dusk.”
“Mmm,” Shijie nodded. “Worms.”
And she teetered off, in the direction of her silkworm hut. Mu Xia followed helplessly. As Shijie pulled a large bundle of mulberry leaves from her storage ring, Mu Xia asked, “Shijie, are you alright?”
Shijie nodded again. “Jss tired. Still got,” she paused, trying to visibly count up her remaining tasks.
That wouldn’t do at all! “No, you’ve got nothing to do until you’re cleaned up and rested!” Mu Xia spread the rest of the leaves over the worms, grabbing Shijie’s arm and pulling her towards the house.
Shijie pulled away before they could enter, detouring to the waterfall. To Mu Xia’s shock, she stood under it for a few minutes, allowing the water to wash away the substances. Then she stripped her clothes off, replacing them with a clean, dry set from her ring, while Mu Xia went “Eep!” and turned around.
Finally, Shijie sat down at her table, Mu Xia across from her. The waterfall had woken her up enough to speak in full sentences, so when Mu Xia set down the basket and opened the lid, her eyes lit up and she said, “Dumplings! Thank you Mu-shimei, I was starting to get hungry.”
“Aren’t you capable of inedia?” It wasn’t healthy, to survive on inedia for too long, but at the very least it prevented the feeling of hunger. Shijie didn't usually rely on it, but it was useful when she went to the secret realms and didn't want to fill up her storage rings with food.
Shijie made a noise of affirmation and swallowed her dumpling. “Yeah, but not for more than a few days. Maybe once I hit Core, but not yet.”
Mu Xia subtly pushed the plate closer. “What were you doing anyways?”
“I needed more golden disks. I used them all up learning spells, which means I don’t have enough for research and development, or to upgrade my axe.” Shijie ate another dumpling. Jin Li crept off of his nest and sniffed at one, then wrinkled his nose. “If I can do that, I can get past those ironwood tree roots that are blocking the path to the eastern forest, see if I can find out what’s in there. Maybe there’s a great treasure that we can use to rebuild the sect.” She looked critically at the half of a dumpling she was holding. “Do you think I can get seeds for chives? I’d like some more aromatics to work with, and these are good. Do you have the recipe?”
Mu Xia nodded. “I finished developing it today. If you liked them, I was going to introduce them to the inn menu.” Shijie had very good taste. If she liked something, odds were it would do well with many customers.
“The usual arrangement then.” Ingredients, to repay the time Mu Xia spent developing her recipe, and to thank her for her generosity. “Assuming I can get chive seeds in.”
“If you can, I’ll see about getting more recipes with them in.” Mu Xia fidgeted with her sleeve. “Shijie, is that. Is that how you usually look when you leave town for a few days?”
Shijie huffed, offended. “I wasn’t gone for a few days, I have to be back every day to feed the worms. They’re very important Mu-shimei.”
“Of course,” she said, conciliatory. “But why didn’t I see you yesterday then?”
A long moment of silence. Shijie was more awake, but still not to her usual calibre, it seemed, as it was taking her a minute to think that through. “Oh, I guess I did feed them at 3 in the morning yesterday. And the day before. And then it was straight back to the desert.”
“Shijie! How long has it been since you slept?” Another long pause, that Mu Xia didn’t let her finish. “Go to bed! Right now!”
“But I have to sweep the forest for flowers, and then I have to schedule some classes for tomorrow, and I need more krill so I have to fish some of those up tonight, and having more pearl dust is always useful and -”
“Go to bed!”
It took another few minutes of corralling her, but eventually Shijie was laying in her bed, Jin Li curled smugly on her chest, preventing her form moving. In just a few seconds, she was asleep.
Mu Xia breathed a sigh of relief. Then she got out her paper crane talisman. Shijie did so much for them. They could do a few things for her, at least for tonight.
#immortal Life#Mu Xia#Ji Yaohua#Li Mengqing#Did I intend the entire cast to be the girls? No#that's just kinda how it worked out when I was planning this out while walking six blocks in ten minutes to get to my next class#Based on various Elder Farmer discussions we've had on the discord#where Elder Farmer emerges from the mines after a week with a heart rending cry of 'MY WORMS!!!!'#or Elder Farmer mediates an argument between townspeople (because Elder Farmer is an Elder now and supposedly has the authority to do that)#and instead of offering advice just puts the two arguers to work on the potatoes#Elder Farmer is a Mess#is how most of us play I think#Terrible sleep schedule because there's no enforced bed time#staying in the realms for days on end#only emerging to Feed the Worms and harvest crops I guess#Chives sadly aren't available in game. Neither western chives nor Chinese chives (which these are supposed to be)#I guess green onions are but also. Not the same#there's also no garlic which I Suffer about daily#anyways play Immortal Life#it's a really cute farming game about rebuilding a cultivation sect after FIRE RAINS DOWN FROM THE SKY and destroys it#and there's an overarching plot of trying to find out why the fire rained down from the sky and destroyed the sect#and all the characters are so well written and unique and they all have strengths and flaws and they're so good and I love them all#Mu Xia got the spotlight here but I may do things with the others later#uh in case it wasn't clear don't be like Elder Farmer. Eat well. Sleep well. Don't forget to feed your worms.#Loxie's fics
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zenaidamacrouras1 · 10 months
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I need help finding a poem!
It's titled something like "For all the fairy boys" or something but when I try to google that I get like, children's books. I've been looking on and off for a while and thought I'd try here
It's a poem that celebrates little fairy princes, young effeminate queer boys and their special magic to hold an audience, to exude joy.
There's this undercurrent of grief because the world can't appreciate the beauty and tries to crush it, but it's mainly a celebration of fairy boys and the men they turn into.
Any help reblogging would be great! It's very important to me for reasons.
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safetycourses2022 · 1 month
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instaviewpoint · 23 days
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New Beers Eve, Chinese Syringes, and Emergency Use Authorization
New Beers Eve, Chinese Syringes, and Emergency Use Authorization April 6 2024 by PK Morgan Yes, it’s New Beers Eve! That’s not a typo. April 7 1933 was the official day that prohibition ended. So, grab a beer this Saturday night and enjoy your freedom from government oppression. The newest and latest oppressive tax out of worker’s pockets circulate to the climate activists who have been…
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rodspurethoughts · 1 year
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FDA Approves Fast and Convenient Azure Fastep COVID-19 Antigen Pen Home Test for Symptomatic and Asymptomatic Individuals
The FDA has issued emergency use authorization for the Azure Fastep COVID-19 Antigen Pen Home Test, manufactured by Azure Biotech, Inc. Validation data for this test was gathered through the National Institutes of Health Independent Test Assessment Program, a collaboration between the FDA and the NIH. This test is specifically designed for serial testing for symptomatic individuals within the…
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paganinpurple · 1 year
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AO3 Etiquette -UPDATED
Based on both decent and not so decent replies, I have made some changes to my original post below.
It would seem a whole new kind of AO3 reader/writer is emerging and it is becoming clear not everyone quite understands how the website community works. Here is some basic guidance on how most people expect you to go about using AO3 to keep this a fun community archive that funtions correctly:
As well as likes, kudos is for when the story was interesting enough to make you finish reading. If it sucked or was badly written, you probably left. If you finished it, you liked it - so kudos.
If you really liked it, you should try to comment. It can be long and detailed or a literal keysmash. Writers don't care, we just love comments.
No critisism unless the author has specifically asked or agreed to hear it (so use your notes to say if you want some constructive feedback). Even constructive critisism is a no-no unless an author note tells you it's okay. No, posting it online is not an open invitation for that. Many people write as a fun hobby or a way to cope with, among other things, insecurity and just want to share. Don't ruin that for them. I've seen so many authors just stop writing coz they can't handle the negative emotions the critism brings, and it's only meant to be a fun thing shared for free (pointing out tagging errors is not included in this).
Do not comment to ask the author to write/update something else. It's tacky and off-putting and will probably have the opposite effect than the one you want.
There is no algorithm, it's an archive. Use the search and filter function to add/remove the pairings/characters/tropes etc. you want to read about and it will find you the fics that fit the bill.
For this to work, writers must tag and rate stories. This avoids readers finding the wrong things and missing the stuff they want. I don't care how cringy that trope is in your eyes - it gets tagged.
The tag exception is if you don't want to tag a million things or spoil your story, you can rate it as "chose not to use warnings," and maybe tag the bare minimum.
Don't censor tags. How can someone exclude a tag if the word isn't typed out correctly? There are no content bans for terms so don't censor them.
If the tags are mostly content/trigger warnings, especially if they are things considered very fucked up or graphic, you might want to use "dead dove - do not eat" to ensure people know that you're not messing around with tags and what they get is exactly what you've warned them about.
Character A/Character B means a ROMANTIC or SEXUAL relationship of some kind. Character A&Character B is PLATONIC, like friendship or family.
Nothing is banned. This is an rule because banning one thing is a slipperly slope to banning another and another, until nothing is allowed anymore. Do not expect anyone to censor for you. Because of the tags system, you are responsible for your own reading experience.
People can create new chapters and sequels/fic series any time after they "complete" a story. So it's considered perfectly normal to subscribe, even to a finished story. You can even subscribe to the author instead just to cover your bases.
Do not repost stories or change the publishing date without an extremely good reason (like a complete top to bottom rewrite or an exchange youve written for going public). It's an archive, not social media. No one cares what's the most recent, only what fits their tag needs.
Instead of deleting a story you wrote if you hate it - consider making it anonymous or orphaning it so others can still enjoy it, without it being connected to your name anymore. If you still want to delete it, fair enough.
It's come to my attention that metaworks ARE allowed on AO3, which is something I wasn't aware of. So if you do post an essay or theory, please tag it as such so others can choose to search for it or exclude it. Art is also allowed.
The only reason this archive works is because NON ONE PROFITS. Do not link to your ko-fi or patreon or mention monetary gain in any way or you violate the terms and risk having your account removed. If anyone does link, it leaves the archive open to people claiming it's for profit and having the whole thing removed.
I KNOW there's plenty more I missed but I'm trying to cover most of the basics that people seem to be struggling with.
I invite anyone to add to this, but please explain, don't berate.
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meeraoperon · 2 years
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Get prepared for Post Emergency Use of Authorization
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neil-gaiman · 1 year
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I found myself having, not exactly an argument recently, but a highly opinionated conversation with someone who did not believe my assertion that once upon a time there were official Hello Kitty vibrators. With the aid of the Wayback Machine, I found this article, and thought the world at large might enjoy it too...
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Here's the text of the article:
The history of the Hello Kitty vibrator
By Peter Payne October 4, 2004
Sanrio is one of the top character licensors in the world, having more or less created the business model of doing business by creating something that doesn't really exist and licensing its use to other companies. Sanrio produces nothing -- all their characters, like the Little Twin Star, Minna no Ta-bo, Bad Batz-Maru, exist as legal entities and nothing more. Their most successful character, Hello Kitty, or Kitty-chan as she's known in Japan, is now now thirty years old.
One of the many companies that license Sanrio's characters for their products was a Japanese company called Genyo Co. Ltd. Genyo made a wide variety of products, from bento boxes to children's toys to chopsticks, many with the Hello Kitty character on them. They scored big in the late 1990's with an off-the-wall hit, a series of Hello Kitty toys which featured a different Kitty figure from each of Japan's 47 prefectures, each representing something the prefecture was famous for. (The figure from Gunma Prefecture, where we live, represented a wooden kokeshi doll.)
In 1997, Genyo designed a product that would live in infamy: the Hello Kitty vibrating shoulder massager, which really is a shoulder massager (trust us -- it says so on the package). Sanrio approved this design without batting an eye, and the product enjoyed modest sales in toy shops and in family restaurants like Denny's and Coco's. It wasn't until 1999 or so that people began to catch on to the fact that the Hello Kitty massager had other potential uses, and with amazing speed, they started popping up in adult videos in Japan. The next thing anyone knew, they had changed into a cult adult item, sold in vending machines in love hotels -- after all, what self-respecting man wouldn't buy his girl a Hello Kitty vibrator when she asked him for one?
The emergence of the Hello Kitty vibrator as a cult adult item caused friction between Sanrio and Genyo, and Sanrio ordered the company to stop making the units. Genyo refused, since it had paid a lot of money to license Kitty for their products. There seemed nothing Sanrio could do, since they had approved the item for sale (see the official Sanrio sticker on the boxes). The answer came when the Japanese tax authorities raided Genyo on suspicion of tax evasion. It seems that some creative accounting was going on between the president of the company, a Mr. Nakamura, his vice president, and the owner of the factory in China where the units were made. All three were arrested, and Sanrio had the excuse needed to yank Genyo's license. They seized the molds used to make the vibrators and destroyed them.
And so, the sad, weird chapter of the Hello Kitty vibrator is at an end. The last of the Kitty vibes are gone, so now what will the world do for wacky comic -- and sexual -- relief?
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caelstyx · 7 months
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I wanted to highlight examples of actions I've seen people organize to protest the genocide happening in Palestine.
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[ID: A tweet by Demilitarize Western Mass @demilitarizewma that reads “BREAKING. We're blockading all vehicle entrances to the L3Harris facility in Northampton, MA. L3Harris is one of the largest weapons contractors in the world, and they profit from war, the prison industry, and the violent occupation of Palestine..” End ID]
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[ID: A tweet by Rebecca Pierce @aptly_engineerd that reads “Happening now: Jewish emergency protest blockading the San Francisco Federal building in solidarity with Gaza and calling for a ceasefire and end to US complicity in the occupation of Palestinians.” End ID]
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[ID: A tweet by Jewish Voice for Peace @jvplive that reads “JEWS SAY: STOP THE GENOCIDE OF PALESTINIANS! Over two-thousand Jews protested in front of the offices and homes of elected officials in NYC, San Francisco, Chicago, Seattle, Indiana, Florida, and Los Angeles to demand action to prevent the genocide of Palestinians..” End ID]
Last thing I wanted to highlight was this message from Palestinian-American Author Nadia Shammas. You can read the full thread on twitter.
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[ID: A tweet by Nadia Shammas @Nadia_Shammas_ that reads “I want to hear non-Palestinians to hold the same faith in their heart as we do that Palestine will be liberated. I dream of a world where, when it’s too painful to keep faith, I can rest knowing they’ll believe it just as hard for me, that they’ll carry it for me just as firm"]
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The latest questions are centered around Anat Schwartz, an Israeli who co-authored several of the paper’s most widely circulated reports, including the now well-known and scrutinized December 28 article headlined: “‘Screams Without Words’’ How Hamas Weaponized Sexual Violence on Oct. 7.” Independent researchers scrutinized the online record, and raised serious questions about Schwartz. First, she has apparently never been a reporter but is actually a filmmaker, who the Times suddenly hired in October. You would expect the paper to look for someone with actual journalistic experience, especially for a story as sensitive as this one, written during the fog of war. Surely the paper had enough of its own correspondents on staff who could have been assigned to it. Next, the researchers found that Schwartz had not hidden her strong feelings online. There are screenshots of her “liking” certain posts that repeated the “40 beheaded baby” hoax, and that endorsed another hysterical post that urged the Israeli army to “turn Gaza into a slaughterhouse,” and called Palestinians “human animals.” (Just this morning, more evidence emerged online; Schwartz apparently also served in Israeli Military Intelligence.) Finally, one of her co-authors on two of the reports was Adam Sella, who is her nephew.  Let’s pause here. What would happen if the Times suddenly hired a Palestinian filmmaker with no journalistic background, who had recently publicly “liked” posts that called for “pushing Israeli Jews into the sea,” to co-write several of its most sensitive and contested reports? 
[...]
There’s another related example of how the Times has botched the sexual violence story. One of the first Israeli organizations that arrived on the scene of the Hamas attack was Zaka, a volunteer group that recovers dead bodies. On January 15, Times reporter Sheena Frankel wrote a positive profile of the group; she included 3 or 4 sentences of criticism, only to quickly dismiss them. This site had already raised serious doubts about Zaka weeks earlier, pointing out that “the organization’s volunteers have systematically given false testimonies, and continue repeating them to journalists on behalf of the Israel government.” Then, on January 31, the Israeli daily Haaretz published a long investigation, that highlighted “cases of negligence, misinformation and a fundraising campaign that used the dead as props.” Haaretz cited one Zaka report that said a volunteer had seen a murdered pregnant woman, with the baby still attached by the umbilical cord — before concluding that the incident “simply didn’t happen.” At this stage, there are serious doubts about many aspects of Israel’s overall account about October 7. Only a genuinely independent and impartial investigation might some day get closer to the truth. But meanwhile, at the very least the New York Times must publicly recognize its errors, and assign new, unbiased reporters to try to clean up its mess. 
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