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#fda

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M. Ní Sídach<p>I find it deeply disturbing how responsible <a href="https://sfba.social/tags/RFK" class="mention hashtag" rel="nofollow noopener" target="_blank">#<span>RFK</span></a> Jr. can make crazy sound when he puts his mind to it.<br><a href="https://sfba.social/tags/US" class="mention hashtag" rel="nofollow noopener" target="_blank">#<span>US</span></a> <a href="https://sfba.social/tags/Politics" class="mention hashtag" rel="nofollow noopener" target="_blank">#<span>Politics</span></a> <a href="https://sfba.social/tags/Science" class="mention hashtag" rel="nofollow noopener" target="_blank">#<span>Science</span></a> <a href="https://sfba.social/tags/antiScience" class="mention hashtag" rel="nofollow noopener" target="_blank">#<span>antiScience</span></a> <a href="https://sfba.social/tags/Project2025" class="mention hashtag" rel="nofollow noopener" target="_blank">#<span>Project2025</span></a> <a href="https://sfba.social/tags/CDC" class="mention hashtag" rel="nofollow noopener" target="_blank">#<span>CDC</span></a> <a href="https://sfba.social/tags/FDA" class="mention hashtag" rel="nofollow noopener" target="_blank">#<span>FDA</span></a></p>
FDA Recall Bot<p>FDA RECALL<br>Brand: Peeters and Aunt Mid’s<br>Product: Fresh sliced and Cremini sliced mushrooms<br>Issue: Potential Foodborne Illness - Listeria monocytogenes<br>Date: 07/11/2025<br>More: <a href="https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/wiet-peeters-farm-products-limited-recalls-aunt-mids-fresh-sliced-mushrooms-peeters-mushroom-farm" rel="nofollow noopener" translate="no" target="_blank"><span class="invisible">https://www.</span><span class="ellipsis">fda.gov/safety/recalls-market-</span><span class="invisible">withdrawals-safety-alerts/wiet-peeters-farm-products-limited-recalls-aunt-mids-fresh-sliced-mushrooms-peeters-mushroom-farm</span></a> <a href="https://m.ai6yr.org/tags/FDA" class="mention hashtag" rel="nofollow noopener" target="_blank">#<span>FDA</span></a> <a href="https://m.ai6yr.org/tags/recall" class="mention hashtag" rel="nofollow noopener" target="_blank">#<span>recall</span></a></p>
Bruce Mirken<p>No, the <a href="https://mas.to/tags/FDA" class="mention hashtag" rel="nofollow noopener" target="_blank">#<span>FDA</span></a> did NOT grant full approval to Moderna's <a href="https://mas.to/tags/COVID" class="mention hashtag" rel="nofollow noopener" target="_blank">#<span>COVID</span></a> <a href="https://mas.to/tags/vaccine" class="mention hashtag" rel="nofollow noopener" target="_blank">#<span>vaccine</span></a> for kids. The media got it wrong. <a href="https://www.medpagetoday.com/opinion/faustfiles/116470?xid=nl_mpt_DHE_2025-07-11&amp;mh=94a3ffbf5efe5196113f4b100e6cb951&amp;zdee=gAAAAABoE23NTssIYTtSXY1LNnohGJaXAfxVFk3sLQUV_-a3Jg6H4sLYZSzhHq472hWcUyzpLu_H7KI5XGZij861NIwwo4RTcZ3VS4TgbTYGcKYWEoniicQ%3D&amp;utm_source=Sailthru&amp;utm_medium=email&amp;utm_campaign=Daily%20Headlines%20Evening%20-%20Randomized%202025-07-11&amp;utm_term=NL_Daily_DHE_dual-gmail-definition" rel="nofollow noopener" translate="no" target="_blank"><span class="invisible">https://www.</span><span class="ellipsis">medpagetoday.com/opinion/faust</span><span class="invisible">files/116470?xid=nl_mpt_DHE_2025-07-11&amp;mh=94a3ffbf5efe5196113f4b100e6cb951&amp;zdee=gAAAAABoE23NTssIYTtSXY1LNnohGJaXAfxVFk3sLQUV_-a3Jg6H4sLYZSzhHq472hWcUyzpLu_H7KI5XGZij861NIwwo4RTcZ3VS4TgbTYGcKYWEoniicQ%3D&amp;utm_source=Sailthru&amp;utm_medium=email&amp;utm_campaign=Daily%20Headlines%20Evening%20-%20Randomized%202025-07-11&amp;utm_term=NL_Daily_DHE_dual-gmail-definition</span></a></p>
Maggie Maybe<p>So I guess this means I can’t get covid tests from Altruan anymore since it’s not an FDA approved product? 😢 </p><p>New FDA Rule Requires Screening of All Imported Food, Drugs, and Health Products—No Exceptions for Low-Value Shipments : r/TrumpTariffNews <a href="https://www.reddit.com/r/TrumpTariffNews/comments/1lwq3h4/new_fda_rule_requires_screening_of_all_imported/" rel="nofollow noopener" translate="no" target="_blank"><span class="invisible">https://www.</span><span class="ellipsis">reddit.com/r/TrumpTariffNews/c</span><span class="invisible">omments/1lwq3h4/new_fda_rule_requires_screening_of_all_imported/</span></a> </p><p><a href="https://zeroes.ca/tags/tariffs" class="mention hashtag" rel="nofollow noopener" target="_blank">#<span>tariffs</span></a> <a href="https://zeroes.ca/tags/FDA" class="mention hashtag" rel="nofollow noopener" target="_blank">#<span>FDA</span></a></p>
George E. 🇺🇸♥🇺🇦🇵🇸🏳️‍🌈🏳️‍⚧️<p>No way would I trust <i>anything</i> to come out of this <a href="https://bofh.social/tags/FDA" rel="nofollow noopener" target="_blank">#FDA</a> right now. This is no longer an <a href="https://bofh.social/tags/agency" rel="nofollow noopener" target="_blank">#agency</a> that values <a href="https://bofh.social/tags/science-based" rel="nofollow noopener" target="_blank">#science-based</a> <a href="https://bofh.social/tags/facts" rel="nofollow noopener" target="_blank">#facts</a> but an agency run by a bunch of sycophants and industry "elites". Thanks, but no thanks. I'll wait a while to see how many <a href="https://bofh.social/tags/dogs" rel="nofollow noopener" target="_blank">#dogs</a><span> end up dying as a result of this shit before I'd even consider giving it to my dogs.<br><br></span><a href="https://abcnews.go.com/Health/fda-approves-long-acting-flea-tick-treatment-dogs/story?id=123656253" rel="nofollow noopener" target="_blank">https://abcnews.go.com/Health/fda-approves-long-acting-flea-tick-treatment-dogs/story?id=123656253</a></p>
Jason Beets<p>A demonstrator holds a sign that features the logos of various government agencies. The sign reads, "Attacked by Trump. Fight Back America!" </p><p>4/x </p><p><a href="https://newsie.social/tags/USA" class="mention hashtag" rel="nofollow noopener" target="_blank">#<span>USA</span></a> <a href="https://newsie.social/tags/Politics" class="mention hashtag" rel="nofollow noopener" target="_blank">#<span>Politics</span></a> <a href="https://newsie.social/tags/Trump" class="mention hashtag" rel="nofollow noopener" target="_blank">#<span>Trump</span></a> <a href="https://newsie.social/tags/CDC" class="mention hashtag" rel="nofollow noopener" target="_blank">#<span>CDC</span></a> <a href="https://newsie.social/tags/USDA" class="mention hashtag" rel="nofollow noopener" target="_blank">#<span>USDA</span></a> <a href="https://newsie.social/tags/FDA" class="mention hashtag" rel="nofollow noopener" target="_blank">#<span>FDA</span></a> <a href="https://newsie.social/tags/SNAP" class="mention hashtag" rel="nofollow noopener" target="_blank">#<span>SNAP</span></a> <a href="https://newsie.social/tags/PBS" class="mention hashtag" rel="nofollow noopener" target="_blank">#<span>PBS</span></a> <a href="https://newsie.social/tags/NATO" class="mention hashtag" rel="nofollow noopener" target="_blank">#<span>NATO</span></a> <a href="https://newsie.social/tags/Protest" class="mention hashtag" rel="nofollow noopener" target="_blank">#<span>Protest</span></a></p>
Maggie Maybe<p>I don’t mind AI having a second look at radiology imaging as long as a human being checks it out too, but I don’t want AI running the Surgical robot during any surgery I might have. I’m going to bookmark this list just in case I need to check it later on.</p><p>FDA AI-Enabled Medical Device List:</p><p><a href="https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intelligence-enabled-medical-devices" rel="nofollow noopener" translate="no" target="_blank"><span class="invisible">https://www.</span><span class="ellipsis">fda.gov/medical-devices/softwa</span><span class="invisible">re-medical-device-samd/artificial-intelligence-enabled-medical-devices</span></a> </p><p><a href="https://zeroes.ca/tags/FDA" class="mention hashtag" rel="nofollow noopener" target="_blank">#<span>FDA</span></a> <a href="https://zeroes.ca/tags/AI" class="mention hashtag" rel="nofollow noopener" target="_blank">#<span>AI</span></a></p>
Brittany Trang<p>New: The FDA today published &gt;200 drug rejection letters, saying it is "Embracing Radical Transparency"</p><p>But most, if not all, of these letters were already public.</p><p>“This is the lowest of the low-hanging fruit. It’s the rest of it that’s hard.”</p><p>Read more about the multiple reasons this isn't as juicy as it seems:</p><p><a href="https://www.statnews.com/2025/07/10/fda-publishes-drug-rejection-letters-marty-makary-transparency-effort/" rel="nofollow noopener" translate="no" target="_blank"><span class="invisible">https://www.</span><span class="ellipsis">statnews.com/2025/07/10/fda-pu</span><span class="invisible">blishes-drug-rejection-letters-marty-makary-transparency-effort/</span></a></p><p><a href="https://newsie.social/tags/health" class="mention hashtag" rel="nofollow noopener" target="_blank">#<span>health</span></a> <a href="https://newsie.social/tags/healthcare" class="mention hashtag" rel="nofollow noopener" target="_blank">#<span>healthcare</span></a> <a href="https://newsie.social/tags/medicine" class="mention hashtag" rel="nofollow noopener" target="_blank">#<span>medicine</span></a> <a href="https://newsie.social/tags/pharma" class="mention hashtag" rel="nofollow noopener" target="_blank">#<span>pharma</span></a> <a href="https://newsie.social/tags/fda" class="mention hashtag" rel="nofollow noopener" target="_blank">#<span>fda</span></a> <a href="https://newsie.social/tags/hhs" class="mention hashtag" rel="nofollow noopener" target="_blank">#<span>hhs</span></a> <a href="https://newsie.social/tags/rfk" class="mention hashtag" rel="nofollow noopener" target="_blank">#<span>rfk</span></a></p>
DoomsdaysCW<p>So, like, why isn't <a href="https://kolektiva.social/tags/RFKjr" class="mention hashtag" rel="nofollow noopener" target="_blank">#<span>RFKjr</span></a> focusing on this shit?!! Oh, 'cuz the bossman is a total <a href="https://kolektiva.social/tags/Corporate" class="mention hashtag" rel="nofollow noopener" target="_blank">#<span>Corporate</span></a> SUCK UP!</p><p><a href="https://kolektiva.social/tags/Weedkiller" class="mention hashtag" rel="nofollow noopener" target="_blank">#<span>Weedkiller</span></a> ingredient widely used in US can damage organs and gut bacteria, research shows</p><p><a href="https://kolektiva.social/tags/Diquat" class="mention hashtag" rel="nofollow noopener" target="_blank">#<span>Diquat</span></a> is banned in the UK, EU, China and other countries. The US has resisted calls to regulate it </p><p>Tom Perkins<br>Sun 6 Jul 2025</p><p><a href="https://www.theguardian.com/environment/2025/jul/06/weedkiller-diquat-organ-damage-study" rel="nofollow noopener" translate="no" target="_blank"><span class="invisible">https://www.</span><span class="ellipsis">theguardian.com/environment/20</span><span class="invisible">25/jul/06/weedkiller-diquat-organ-damage-study</span></a></p><p><a href="https://kolektiva.social/tags/Pesticides" class="mention hashtag" rel="nofollow noopener" target="_blank">#<span>Pesticides</span></a> <a href="https://kolektiva.social/tags/FDA" class="mention hashtag" rel="nofollow noopener" target="_blank">#<span>FDA</span></a> <a href="https://kolektiva.social/tags/USPol" class="mention hashtag" rel="nofollow noopener" target="_blank">#<span>USPol</span></a> <a href="https://kolektiva.social/tags/FDAFail" class="mention hashtag" rel="nofollow noopener" target="_blank">#<span>FDAFail</span></a> <a href="https://kolektiva.social/tags/BigAg" class="mention hashtag" rel="nofollow noopener" target="_blank">#<span>BigAg</span></a> <a href="https://kolektiva.social/tags/BigChem" class="mention hashtag" rel="nofollow noopener" target="_blank">#<span>BigChem</span></a></p>
Bích-Mây Nguyễn :verified:<p>"More and more, people seemed to clamor for things that were unproven, to question things that were and to express not only mistrust but outright hostility toward the doctors, scientists and civil servants trying to separate one from the other. That hostility was being nourished by exactly the kind of mis- and disinformation Kennedy was espousing. It was easy to paint the F.D.A. as a supervillain."</p><p><a href="https://www.nytimes.com/2025/07/08/magazine/fda-collapse-rfk-kennedy.html?searchResultPosition=1" rel="nofollow noopener" translate="no" target="_blank"><span class="invisible">https://www.</span><span class="ellipsis">nytimes.com/2025/07/08/magazin</span><span class="invisible">e/fda-collapse-rfk-kennedy.html?searchResultPosition=1</span></a> </p><p><a href="https://med-mastodon.com/tags/healthcare" class="mention hashtag" rel="nofollow noopener" target="_blank">#<span>healthcare</span></a> <a href="https://med-mastodon.com/tags/PublicHealth" class="mention hashtag" rel="nofollow noopener" target="_blank">#<span>PublicHealth</span></a> <a href="https://med-mastodon.com/tags/FDA" class="mention hashtag" rel="nofollow noopener" target="_blank">#<span>FDA</span></a> <a href="https://med-mastodon.com/tags/HHS" class="mention hashtag" rel="nofollow noopener" target="_blank">#<span>HHS</span></a> <a href="https://med-mastodon.com/tags/misinformation" class="mention hashtag" rel="nofollow noopener" target="_blank">#<span>misinformation</span></a> <a href="https://med-mastodon.com/tags/longread" class="mention hashtag" rel="nofollow noopener" target="_blank">#<span>longread</span></a></p>
Maggie Maybe<p>This is great, except the RASH DOES NOT ALWAYS SHOW UP AT THE BITE LOCATION.</p><p>It’s important that people know this. If you have a tick bite from what I understand they have to be attached for almost 24 hours to transmit lyme disease if they have it.</p><p>But if you’re checking for the bull’s-eye rash you need someone to look everywhere because it doesn’t always show up at the location of the bite.</p><p>And if you think you’ve been infected if you get antibiotics right away you can be OK.</p><p>From the link:</p><p>“FDA Issues Final Guidance on Drug Development for Early Lyme Disease<br>The U.S. Food and Drug Administration (FDA) has issued a final guidance for industry, Early Lyme Disease as Manifested by Erythema Migrans: Developing Drugs for Treatment. Early localized disease occurs within one month after a tick bite and is characterized by erythema migrans (EM), a rash at the site of the bite that may be accompanied by nonspecific symptoms (e.g., fatigue, muscle pain). Early disseminated disease occurs days to months after the tick bite and is characterized by multiple EM lesions, often away from the bite site, as well as potential neurologic and cardiac symptoms.<br>This final guidance describes FDA’s current recommendations on drug development considerations for the treatment of early Lyme disease (i.e., early localized and early disseminated disease), including trial population, trial design, safety, and efficacy among other considerations.”<br><a href="https://content.govdelivery.com/accounts/USFDA/bulletins/3e8a911" rel="nofollow noopener" translate="no" target="_blank"><span class="invisible">https://</span><span class="ellipsis">content.govdelivery.com/accoun</span><span class="invisible">ts/USFDA/bulletins/3e8a911</span></a> </p><p><a href="https://zeroes.ca/tags/FDA" class="mention hashtag" rel="nofollow noopener" target="_blank">#<span>FDA</span></a> <a href="https://zeroes.ca/tags/lymesdisease" class="mention hashtag" rel="nofollow noopener" target="_blank">#<span>lymesdisease</span></a> <a href="https://zeroes.ca/tags/lyme" class="mention hashtag" rel="nofollow noopener" target="_blank">#<span>lyme</span></a></p>
FDA Recall Bot<p>FDA RECALL<br>Brand: Ritz<br>Product: Peanut butter cracker sandwiches<br>Issue: Undeclared Allergen – Peanut<br>Date: 07/08/2025<br>More: <a href="https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/mondelez-global-llc-conducts-us-voluntary-recall-four-carton-sizes-ritz-peanut-butter-cracker" rel="nofollow noopener" translate="no" target="_blank"><span class="invisible">https://www.</span><span class="ellipsis">fda.gov/safety/recalls-market-</span><span class="invisible">withdrawals-safety-alerts/mondelez-global-llc-conducts-us-voluntary-recall-four-carton-sizes-ritz-peanut-butter-cracker</span></a> <a href="https://m.ai6yr.org/tags/FDA" class="mention hashtag" rel="nofollow noopener" target="_blank">#<span>FDA</span></a> <a href="https://m.ai6yr.org/tags/recall" class="mention hashtag" rel="nofollow noopener" target="_blank">#<span>recall</span></a></p>
Greg Lloyd<p><a href="https://federate.social/tags/giftlink" class="mention hashtag" rel="nofollow noopener" target="_blank">#<span>giftlink</span></a> <a href="https://federate.social/tags/nytimes" class="mention hashtag" rel="nofollow noopener" target="_blank">#<span>nytimes</span></a> <a href="https://federate.social/tags/fda" class="mention hashtag" rel="nofollow noopener" target="_blank">#<span>fda</span></a><br><a href="https://www.nytimes.com/2025/07/08/magazine/fda-collapse-rfk-kennedy.html?unlocked_article_code=1.U08.H3C8.4L9nZ91Rz8Zl&amp;smid=nytcore-ios-share&amp;referringSource=articleShare" rel="nofollow noopener" translate="no" target="_blank"><span class="invisible">https://www.</span><span class="ellipsis">nytimes.com/2025/07/08/magazin</span><span class="invisible">e/fda-collapse-rfk-kennedy.html?unlocked_article_code=1.U08.H3C8.4L9nZ91Rz8Zl&amp;smid=nytcore-ios-share&amp;referringSource=articleShare</span></a></p>
Bích-Mây Nguyễn :verified:<p>"The takedowns were carried out in late January to comply with an executive order from President Donald Trump redirecting the federal government’s stance on gender and sex policy. They were restored in part when a plaintiff medical organization, Doctors for America, was granted a temporary restraining order after successfully arguing that the sudden removals impeded their ability to provide time-sensitive care..."</p><p><a href="https://www.fiercehealthcare.com/regulatory/judge-vacates-trump-administrations-removal-health-web-pages" rel="nofollow noopener" translate="no" target="_blank"><span class="invisible">https://www.</span><span class="ellipsis">fiercehealthcare.com/regulator</span><span class="invisible">y/judge-vacates-trump-administrations-removal-health-web-pages</span></a></p><p><a href="https://med-mastodon.com/tags/healthcare" class="mention hashtag" rel="nofollow noopener" target="_blank">#<span>healthcare</span></a> <a href="https://med-mastodon.com/tags/PublicHealth" class="mention hashtag" rel="nofollow noopener" target="_blank">#<span>PublicHealth</span></a> <a href="https://med-mastodon.com/tags/gender" class="mention hashtag" rel="nofollow noopener" target="_blank">#<span>gender</span></a> <a href="https://med-mastodon.com/tags/HHS" class="mention hashtag" rel="nofollow noopener" target="_blank">#<span>HHS</span></a> <a href="https://med-mastodon.com/tags/CDC" class="mention hashtag" rel="nofollow noopener" target="_blank">#<span>CDC</span></a> <a href="https://med-mastodon.com/tags/FDA" class="mention hashtag" rel="nofollow noopener" target="_blank">#<span>FDA</span></a> <a href="https://med-mastodon.com/tags/courts" class="mention hashtag" rel="nofollow noopener" target="_blank">#<span>courts</span></a></p>
Bích-Mây Nguyễn :verified:<p>From a Doctors for America email: "A federal judge ruled in favor of Doctors for America and the City and County of San Francisco in our lawsuit challenging the unlawful removal of vital health information from government websites...The court's ruling requires the government to restore the webpages and datasets DFA and others rely on, and invalidates the federal policies that led to their removal."</p><p>Decision: <a href="https://drive.google.com/file/d/16Xcm0LfMf7gUb-hLG8GAVtuio0GLoJ77/view" rel="nofollow noopener" translate="no" target="_blank"><span class="invisible">https://</span><span class="ellipsis">drive.google.com/file/d/16Xcm0</span><span class="invisible">LfMf7gUb-hLG8GAVtuio0GLoJ77/view</span></a> </p><p><a href="https://med-mastodon.com/tags/healthcare" class="mention hashtag" rel="nofollow noopener" target="_blank">#<span>healthcare</span></a> <a href="https://med-mastodon.com/tags/PublicHealth" class="mention hashtag" rel="nofollow noopener" target="_blank">#<span>PublicHealth</span></a> <a href="https://med-mastodon.com/tags/CDC" class="mention hashtag" rel="nofollow noopener" target="_blank">#<span>CDC</span></a> <a href="https://med-mastodon.com/tags/HHS" class="mention hashtag" rel="nofollow noopener" target="_blank">#<span>HHS</span></a> <a href="https://med-mastodon.com/tags/FDA" class="mention hashtag" rel="nofollow noopener" target="_blank">#<span>FDA</span></a> <a href="https://med-mastodon.com/tags/HRSA" class="mention hashtag" rel="nofollow noopener" target="_blank">#<span>HRSA</span></a> <a href="https://med-mastodon.com/tags/CMS" class="mention hashtag" rel="nofollow noopener" target="_blank">#<span>CMS</span></a> <a href="https://med-mastodon.com/tags/courts" class="mention hashtag" rel="nofollow noopener" target="_blank">#<span>courts</span></a></p>
Helen Branswell<p>Low morale, layoffs &amp; voluntary departures, and distrust of the new leadership is hindering the functioning of the <a href="https://scicomm.xyz/tags/FDA" class="mention hashtag" rel="nofollow noopener" target="_blank">#<span>FDA</span></a>, my colleague Lizzy Lawrence reports. <br>This is hardly the recipe for an effective drug regulatory agency. <a href="https://www.statnews.com/2025/07/07/fda-job-cuts-morale-low-staff-anxious-impact-of-new-leadership-makary-prasad-rfk-jr/" rel="nofollow noopener" translate="no" target="_blank"><span class="invisible">https://www.</span><span class="ellipsis">statnews.com/2025/07/07/fda-jo</span><span class="invisible">b-cuts-morale-low-staff-anxious-impact-of-new-leadership-makary-prasad-rfk-jr/</span></a></p>
ProPublica<p>With deep job cuts at the FDA, inspectors say the ongoing strain could compromise policing an industry spread across more than 90 countries.</p><p>“Things will be missed, we are going to have a lot less safe drugs,” a former inspector said.<br><a href="https://www.propublica.org/article/fda-cuts-drug-factory-inspections?utm_source=mastodon&amp;utm_medium=social&amp;utm_campaign=mastodon-post" rel="nofollow noopener" translate="no" target="_blank"><span class="invisible">https://www.</span><span class="ellipsis">propublica.org/article/fda-cut</span><span class="invisible">s-drug-factory-inspections?utm_source=mastodon&amp;utm_medium=social&amp;utm_campaign=mastodon-post</span></a></p><p><a href="https://newsie.social/tags/News" class="mention hashtag" rel="nofollow noopener" target="_blank">#<span>News</span></a> <a href="https://newsie.social/tags/FDA" class="mention hashtag" rel="nofollow noopener" target="_blank">#<span>FDA</span></a> <a href="https://newsie.social/tags/Drugs" class="mention hashtag" rel="nofollow noopener" target="_blank">#<span>Drugs</span></a> <a href="https://newsie.social/tags/Safety" class="mention hashtag" rel="nofollow noopener" target="_blank">#<span>Safety</span></a> <a href="https://newsie.social/tags/Health" class="mention hashtag" rel="nofollow noopener" target="_blank">#<span>Health</span></a> <a href="https://newsie.social/tags/Medicine" class="mention hashtag" rel="nofollow noopener" target="_blank">#<span>Medicine</span></a> <a href="https://newsie.social/tags/Government" class="mention hashtag" rel="nofollow noopener" target="_blank">#<span>Government</span></a></p>
jj the Santa Barbarian<p><a href="https://m.ai6yr.org/tags/FDA" class="mention hashtag" rel="nofollow noopener" target="_blank">#<span>FDA</span></a> Issues Most Serious Risk Level for 20 Million <a href="https://m.ai6yr.org/tags/Eggs" class="mention hashtag" rel="nofollow noopener" target="_blank">#<span>Eggs</span></a> - Newsweek <a href="https://share.google/1g0IdAhWJA4Pqeijb" rel="nofollow noopener" translate="no" target="_blank"><span class="invisible">https://</span><span class="">share.google/1g0IdAhWJA4Pqeijb</span><span class="invisible"></span></a></p>
Brittany Trang<p>A few months ago, a generative AI tool for helping doctors diagnose and treat disease was certified in Europe.</p><p>But what does that mean? And would that device pass FDA muster?</p><p>The FDA, to date, hasn't released guidelines on generative AI medical devices.</p><p>More:<br><a href="https://www.statnews.com/2025/07/03/ai-medical-device-europe-prof-valmed-questions-about-generative-ai/" rel="nofollow noopener" translate="no" target="_blank"><span class="invisible">https://www.</span><span class="ellipsis">statnews.com/2025/07/03/ai-med</span><span class="invisible">ical-device-europe-prof-valmed-questions-about-generative-ai/</span></a></p><p><a href="https://newsie.social/tags/health" class="mention hashtag" rel="nofollow noopener" target="_blank">#<span>health</span></a> <a href="https://newsie.social/tags/healthcare" class="mention hashtag" rel="nofollow noopener" target="_blank">#<span>healthcare</span></a> <a href="https://newsie.social/tags/healthtech" class="mention hashtag" rel="nofollow noopener" target="_blank">#<span>healthtech</span></a> <a href="https://newsie.social/tags/medicaldevices" class="mention hashtag" rel="nofollow noopener" target="_blank">#<span>medicaldevices</span></a> <a href="https://newsie.social/tags/fda" class="mention hashtag" rel="nofollow noopener" target="_blank">#<span>fda</span></a> <a href="https://newsie.social/tags/ai" class="mention hashtag" rel="nofollow noopener" target="_blank">#<span>ai</span></a> <a href="https://newsie.social/tags/artificialintelligence" class="mention hashtag" rel="nofollow noopener" target="_blank">#<span>artificialintelligence</span></a> <a href="https://newsie.social/tags/doctors" class="mention hashtag" rel="nofollow noopener" target="_blank">#<span>doctors</span></a> <a href="https://newsie.social/tags/medmastodon" class="mention hashtag" rel="nofollow noopener" target="_blank">#<span>medmastodon</span></a></p>
Maggie Maybe<p>FYI if your kid sees this doctor:</p><p>Peter Michael, M.D.<br>"Peter Michael, M.D.<br>1401 East 4th Avenue, Suite 201<br>Hialeah, FL 33010-3504<br> for autism the FDA went after him for “overdosing” patients with a medication. (It looks like the doctor confirmed there was a dosing issue, so maybe the FDA isn’t coming for him for treating autistic patients, but idk.)</p><p><a href="https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/peter-michael-md-711299-06182025" rel="nofollow noopener" translate="no" target="_blank"><span class="invisible">https://www.</span><span class="ellipsis">fda.gov/inspections-compliance</span><span class="invisible">-enforcement-and-criminal-investigations/warning-letters/peter-michael-md-711299-06182025</span></a> </p><p><a href="https://zeroes.ca/tags/FDA" class="mention hashtag" rel="nofollow noopener" target="_blank">#<span>FDA</span></a> <a href="https://zeroes.ca/tags/autism" class="mention hashtag" rel="nofollow noopener" target="_blank">#<span>autism</span></a></p>