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42 results for www.fda.gov:

50calPeephole t1_jefjzdy wrote

were still collecting data when first shots in arms were being injected under the EUA. https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization >Under section 564 of the Federal Food, Drug, and Cosmetic Act (FD&C Act), when ... Vaccines were still in phase 3, or wide scale clinical trials looking at safety and efficacy: https://www.fda.gov/vaccines-blood-biologics/vaccines/emergency-use-authorization-vaccines-explained I'm 100% with the FDA on this, the benefits outweighed the risks

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Ash-SeedMustDie t1_jddox6b wrote

www.fda.gov/food/environmental-contaminants-food/lead-food-foodwares-and-dietary-supplements#:\~:text=While%20it%20is%20not%20possible,to%20chemical%20hazards%E2%80%94including%20lead](https://www.fda.gov/food/environmental-contaminants-food/lead-food-foodwares-and-dietary-supplements#:~:text=While%20it%20is%20not%20possible,to%20chemical%20hazards%E2%80%94including%20lead). "While it is not possible to prevent or remove lead entirely from foods, the levels in food

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trnka t1_ispbueg wrote

their criteria for clinical decision support devices for AI last month. This is [the summary version](https://www.fda.gov/medical-devices/software-medical-device-samd/your-clinical-decision-support-software-it-medical-device) and the full version has more detail. It's not hard to have a highly accurate

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Neat_Youth470 t1_isujxn9 wrote

false negative. There’s a large margin of error regarding incubation times and low viral load. https://www.fda.gov/medical-devices/safety-communications/home-covid-19-antigen-tests-take-steps-reduce-your-risk-false-negative-fda-safety-communication#:~:text=However%2C%20if%20you%20perform%20an,t%20have%20COVID-19%20symptoms.

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caolle t1_itt6jie wrote

There's a nationwide shortage: https://www.fda.gov/drugs/drug-safety-and-availability/fda-announces-shortage-adderall

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Eladriol t1_iuqes53 wrote

months (assuming you take the start of the pandemic as roughly mid feb) https://www.fda.gov/news-events/press-announcements/fda-takes-key-action-fight-against-covid-19-issuing-emergency-use-authorization-first-covid-19 That the delivery platform had been under research for decades doesn't mean that every vaccine using that platform

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Ggfd8675 t1_ivvjmim wrote

similar issue with prenatal screens: [https://www.nytimes.com/2022/01/01/upshot/pregnancy-birth-genetic-testing.html](https://www.nytimes.com/2022/01/01/upshot/pregnancy-birth-genetic-testing.html) FDA issued a warning to parents: https://www.fda.gov/medical-devices/safety-communications/genetic-non-invasive-prenatal-screening-tests-may-have-false-results-fda-safety-communication This is a different type of testing than the newborn screen (blood spot cards) you are talking about

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ACMEPrinting t1_iy4ypt5 wrote

confusion but sheds some light into the FDA's thought process on the matter: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/draft-guidance-industry-and-fda-staff-whole-grain-label-statements Note: Link is the opposite of ELI5

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Pittman247 t1_iy9nhbt wrote

Reply to Ritalin shortage by zucca4

Adderall/Ritalin (same class of med): https://www.fda.gov/drugs/drug-safety-and-availability/fda-announces-shortage-adderall

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ksdkjlf t1_j25d9u5 wrote

order of magnitude. [Per the FDA](https://www.fda.gov/radiation-emitting-products/medical-x-ray-imaging/what-are-radiation-risks-ct): "A CT examination with an effective dose of 10 millisieverts [an abdominal CT averages 8] [...] may be associated with an increase in the possibility of fatal

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MCRNRearAdmiral t1_j29unj0 wrote

avoid raw milk, the threat in things like deli meat and hot dogs too is real. https://www.fda.gov/food/foodborne-pathogens/listeria-listeriosis#:~:text=Foods%20Linked%20to%20U.S.%20Outbreaks,L. Want to see how the smart folks in Food Science use viruses to actually combat

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shiruken t1_j69s6bd wrote

were enrolled from November 27, 2021 to June 30, 2022. The bivalent booster was not [authorized](https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-authorizes-moderna-pfizer-biontech-bivalent-covid-19-vaccines-use) until August 31, 2022. That being said, vaccination was still **highly effective** at preventing several maternal

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NOAEL_MABEL t1_jc38vig wrote

integration sites. In fact, The FDA had a CTGTAC meeting in 2021 to discuss these issues: https://www.fda.gov/advisory-committees/cellular-tissue-and-gene-therapies-advisory-committee/2021-meeting-materials-cellular-tissue-and-gene-therapies-advisory-committee

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A_Generic_White_Guy OP t1_jd1y93k wrote

term to refer specifically to genetic engineering. Seems like that's where the difference comes from. https://www.fda.gov/food/agricultural-biotechnology/types-genetic-modification-methods-crops These all are considered genetic modification

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[deleted] t1_jdlux8f wrote

hydrolyzed yeast, yeast extract, soy extracts, and protein isolate, as well as in tomatoes and cheeses." https://www.fda.gov/food/food-additives-petitions/questions-and-answers-monosodium-glutamate-msg#:~:text=MSG%20occurs%20naturally%20in%20many,glutamate%2Drich%20foods%20throughout%20history.

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nanoatzin OP t1_iqpny69 wrote

magnesium levels can be associated with long-term use of Proton Pump Inhibitor drugs (PPIs)](https://www.fda.gov/drugs/drug-safety-and-availability/fda-drug-safety-communication-low-magnesium-levels-can-be-associated-long-term-use-proton-pump) Proper diet is inadequate if intestinal disease or age impairs nutrient absorption. The diagnostic failure rate

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reaper527 t1_jefvb2m wrote

again: https://www.fda.gov/news-events/press-announcements/fda-approves-first-covid-19-vaccine FTA: >For Immediate Release: August 23, 2021 considering [the mandate was announced on august 16, 2021](https://www.boston.gov/news/vaccination-mandate-announced-city-boston-employees), he was right that the mandate preceded the approval. no amount

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techsavior t1_isf6abs wrote

past, [the CDC is limiting the use of the Janssen (J&J) vaccine.](https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-limits-use-janssen-covid-19-vaccine-certain-individuals)

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