Trump may be mystery patient in odd case of 79yo getting experimental obesity drug<br /> by [[Beth Mole]] in Ars Technica<br /> accessed on 2026-06-23T21:06:22

2027年底开业——这给了他们大约18个月来完成从「宣告」到「开业」的全部工程、监管和商业准备。医疗设备在美国需要FDA 510(k)或PMA批准，这个流程通常需要数年。如果「Ultrasonic CT」被认定为新型医疗设备（而非对现有超声设备的改进型），可能需要PMA，周期更长。页面没有提及任何FDA状态——这是评估这个时间线是否可信的关键信息缺口。2027年能否按时开业，很大程度上取决于监管路径是否已经明确。

Ladyzhets, B. (2021, November 9). The U.S. Is Relying On Other Countries’ Data To Make Its Booster Shot Decisions. FiveThirtyEight. https://fivethirtyeight.com/features/the-u-s-is-relying-on-other-countries-data-to-make-its-booster-shot-decisions/

Commissioner, O. of the. (2022). Comirnaty and Pfizer-BioNTech COVID-19 Vaccine. FDA. https://www.fda.gov/emergency-preparedness-and-response/coronavirus-disease-2019-covid-19/comirnaty-and-pfizer-biontech-covid-19-vaccine

Commissioner. (2021, October 29). FDA Authorizes Pfizer-BioNTech COVID-19 Vaccine for Emergency Use in Children 5 through 11 Years of Age. FDA; FDA. https://www.fda.gov/news-events/press-announcements/fda-authorizes-pfizer-biontech-covid-19-vaccine-emergency-use-children-5-through-11-years-age

Lewis, T. (n.d.). Who Needs a COVID Booster Shot? Experts Answer Common Questions. Scientific American. Retrieved April 29, 2022, from https://www.scientificamerican.com/article/who-needs-a-covid-booster-shot-experts-answer-common-questions/

Natalie E. Dean, PhD. (2021, May 4). The imminent FDA authorization of a vaccine for 12-15 year olds is great news, and adolescents should be able to access vaccine. But in the short term, we must also grapple with the ethics of vaccinating adolescents ahead of high-risk adults in other countries. [Tweet]. @nataliexdean. https://twitter.com/nataliexdean/status/1389381649314598914

Yang, M. (2022, February 14). Arkansas jail’s ivermectin experiments recall historical medical abuse of imprisoned minorities. The Guardian. https://www.theguardian.com/us-news/2022/feb/14/arkansas-prison-covid-19-ivermectin-experiment-minorities-medical-abuse

Meg Tirrell. (2022, January 31). Novavax says it’s officially filed for EUA of its #covid19 vaccine in the US https://t.co/QtKunI2sbm [Tweet]. @megtirrell. https://twitter.com/megtirrell/status/1488223548602736640

Moderna wins full approval for its Covid-19 vaccine, as Novavax seeks authorization for its version. (2022, January 31). STAT. https://www.statnews.com/2022/01/31/and-then-there-were-2-fda-gives-full-approval-to-modernas-covid-19-vaccine/

FDA authorizes Pfizer-BioNTech, Moderna boosters for all adults. (2021). Washington Post. Retrieved November 22, 2021, from https://www.washingtonpost.com/health/2021/11/19/fda-clears-pfizer-biontech-moderna-booster-shots-all-adults/

Yang, M. (2021, November 23). Seven doctors contract Covid after attending Florida anti-vaccine summit. The Guardian. https://www.theguardian.com/us-news/2021/nov/23/florida-doctors-covid-coronavirus-bruce-boros

Claims about changes to Pfizer vaccine for children miss important details. (16:48:08.203282+00:00). Full Fact. https://fullfact.org/online/claims-about-changes-pfizer-vaccine-children-miss-important-details/

Covid: US approves Pfizer vaccine for children over five. (2021, November 3). BBC News. https://www.bbc.com/news/world-us-canada-59044853

Reuters. ‘CDC Overrides Advisory Panel to Back Pfizer Booster for Americans with High-Risk Jobs’. The Guardian, 24 September 2021, sec. US news. https://www.theguardian.com/us-news/2021/sep/24/cdc-overrides-advisory-panel-pfizer-booster-americans-high-risk-jobs.

Brockes, E. (2021, November 7). I’ve had a wake-up call on Covid vaccines for children – mine will be first in line. The Guardian. https://www.theguardian.com/commentisfree/2021/nov/07/covid-vaccines-children-us-approval

Frost, M. (n.d.). Busting COVID-19 vaccination myths. Retrieved November 2, 2021, from https://acpinternist.org/archives/2021/11/busting-covid-19-vaccination-myths.htm

Tennessee Bills Would Shield Docs Who Spread COVID Misinformation. (2021, October 29). https://www.medpagetoday.com/special-reports/exclusives/95355

Wu, K. J. (2021, October 27). Five Big Questions About COVID Vaccines for Kids. The Atlantic. https://www.theatlantic.com/health/archive/2021/10/kids-vaccines-q-and-a/620497/

Covering COVID-19 vaccine boosters: 4 tips and a timeline. (n.d.). Retrieved October 25, 2021, from https://journalistsresource.org/home/covid-19-boosters-tip-sheet/

Lee, B. Y. (n.d.). Graphene Oxide In Pfizer Covid-19 Vaccines? Here Are The Latest Unsupported Claims. Forbes. Retrieved 25 October 2021, from https://www.forbes.com/sites/brucelee/2021/07/10/graphene-oxide-in-pfizer-covid-19-vaccines-here-are-the-latest-unsupported-claims/

Gutman, R. (2021, October 14). Should You Mix and Match Your Booster Shot? The Atlantic. https://www.theatlantic.com/health/archive/2021/10/mix-match-booster-covid-vaccine/620395/

Kozlov, Max. ‘COVID-Vaccine Booster Shot Shows Promise in Israeli Study’. Nature, 16 September 2021. https://doi.org/10.1038/d41586-021-02516-4.

Twitter, & Email. (2021, August 20). Vax facts: San Diego researchers debunk 7 common COVID-19 vaccine myths. San Diego Union-Tribune. https://www.sandiegouniontribune.com/news/health/story/2021-08-20/vax-facts-7-common-coronavirus-vaccine-myths-debunked

Commissioner, O. of the. (2021, August 16). Coronavirus (COVID-19) Update: FDA Authorizes Additional Vaccine Dose for Certain Immunocompromised Individuals. FDA. https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-authorizes-additional-vaccine-dose-certain-immunocompromised

The BMJ. ‘Does the FDA Think These Data Justify the First Full Approval of a Covid-19 Vaccine?’, 23 August 2021. https://blogs.bmj.com/bmj/2021/08/23/does-the-fda-think-these-data-justify-the-first-full-approval-of-a-covid-19-vaccine/.

Bard, Jennifer S. ‘6 Actions the Federal Government Should Take in Response to the Delta Variant’. Bill of Health, 27 July 2021. http://blog.petrieflom.law.harvard.edu/2021/07/27/delta-covid-variant-government-response/.

Moderna Completes Submission of Biologics License Application to the U.S. Food and Drug Administration for its COVID-19 Vaccine | Moderna, Inc. (n.d.). Retrieved 26 August 2021, from https://investors.modernatx.com/news-releases/news-release-details/moderna-completes-submission-biologics-license-application-us/

Commissioner, O. of the. (2021). Why You Should Not Use Ivermectin to Treat or Prevent COVID-19. FDA. https://www.fda.gov/consumers/consumer-updates/why-you-should-not-use-ivermectin-treat-or-prevent-covid-19

Holger Hestermeyer. (2021, March 2). As there’s a lot of ‘this is all EU politics’ out there on AZ drug admission: Some food for thought. I have deleted a lot of tweets on this. I will try to be brief, informative and neutral. (Thread) [Tweet]. @hhesterm. https://twitter.com/hhesterm/status/1366703497123672066

‘Johnson & Johnson Vaccine Paused over Rare Blood Clots’. BBC News, 13 April 2021, sec. US & Canada. https://www.bbc.com/news/world-us-canada-56733715.

FDA to add warning about rare heart inflammation to Pfizer, Moderna vaccines | Reuters. (n.d.). Retrieved June 25, 2021, from https://www.reuters.com/business/healthcare-pharmaceuticals/us-panel-review-heart-inflammation-cases-after-pfizer-moderna-vaccines-2021-06-23

Rapid Covid tests used in mass UK programme get scathing US report | Coronavirus | The Guardian. (n.d.). Retrieved June 12, 2021, from https://www.theguardian.com/world/2021/jun/11/us-health-agency-gives-innova-lateral-flow-covid-tests-scathing-review

Lewis, T. (n.d.). COVID-19 Spit Tests Used by NBA Are Now Authorized by FDA. Scientific American. Retrieved August 24, 2020, from https://www.scientificamerican.com/article/covid-19-spit-tests-used-by-nba-are-now-authorized-by-fda/

Isaacson, Walter. ‘Opinion | I Was Part of a Trial for Pfizer’s Covid-19 Vaccine. It’s a Miracle for Genetic Medicine.’ Washington Post. Accessed 6 March 2021. https://www.washingtonpost.com/opinions/i-took-the-pfizer-covid-19-vaccine-its-a-miracle-for-genetic-medicine/2020/11/09/77e652d0-22bf-11eb-952e-0c475972cfc0_story.html.

Nature Editorial. (2020, October 23). The race to make COVID antibody therapies cheaper and more potent. Nature. https://www.nature.com/articles/d41586-020-02965-3?utm_source=twt_nnc&utm_medium=social&utm_campaign=naturenews&sf239165668=1&error=cookies_not_supported&code=2b2dd7c6-d01f-4057-8389-3be656a7ba58

ReconfigBehSci. (2020, December 6). RT @statsepi: Lol ok. Https://t.co/eCPpU3Linv [Tweet]. @SciBeh. https://twitter.com/SciBeh/status/1335894181248643073

Health, C. for D. and R. (2021). Pulse Oximeter Accuracy and Limitations: FDA Safety Communication. FDA. https://www.fda.gov/medical-devices/safety-communications/pulse-oximeter-accuracy-and-limitations-fda-safety-communication

ReconfigBehSci. (2020, November 20). RT @carlquintanilla: History. Pfizer/BioNTech press release, announcing request for FDA vaccine emergency use: $PFE $BNTX https://t.co/iG… [Tweet]. @SciBeh. https://twitter.com/SciBeh/status/1329815278868434946

Emily. J. Miller. - FDA {@FDASpox} (2020) Convalescent plasma has shown to be beneficial for 35% of patients. This risk reduction figure - shown in chart below - is from @MayoClinic data from expanded access program that was analyzed by FDAA for the emergency use authorization announced today. Twitter. Retrieved from: https://twitter.com/FDASpox/status/1297706985039835136

viet nam

Alter, S. M., Maki, D. G., LeBlang, S., Shih, R. D., & Hennekens, C. H. (2020). The menacing assaults on science, FDA, CDC, and health of the US public. EClinicalMedicine, 0(0). https://doi.org/10.1016/j.eclinm.2020.100581

Commissioner, O. of the. (2020, September 23). Coronavirus (COVID-19) Update: FDA Authorizes First Point-of-Care Antibody Test for COVID-19. FDA; FDA. https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-authorizes-first-point-care-antibody-test-covid-19

Matthews, D. (2020, May 20). How exposing healthy volunteers to Covid-19 for vaccine testing would work. Vox. https://www.vox.com/future-perfect/2020/5/20/21258725/covid-19-human-challenge-trials-vaccine-update-sars-cov-2

Semaglutide now included among GLP-1 receptor agonists

In December 2017, the U.S. FDA approved the GLP-1 receptor agonist semaglutide as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes.

Reference:

U.S. Food & Drug Administration. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&applno=209637. Accessed January 1, 2018

Rationale: Approval of new treatments (medications or devices) has the potential to impact patient care.

Annotation published April 11, 2018.

Annotation approved by PPC: March 10, 2018.

Suggested citation: American Diabetes Association. 8. Pharmacologic approaches to glycemic treatment: Standards of Medical Care in Diabetes—2018 [web annotation]. Diabetes Care 2018;41(Suppl. 1):S73–S85. Retrieved from [link to annotation].

Ertugliflozin now included among SGLT2 inhibitors

In December 2017, the U.S. Food and Drug Administration approved the SGLT2 inhibitor ertugliflozin as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes.

Reference:

U.S. Food and Drug Administration. Drugs@FDA: FDA Approved Drug Products. Available from https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&applno=209803. Accessed 1 January 2018

Rationale/Reason for Change: Approval of new treatments (medications or devices) has the potential to impact patient care.

Annotation published April 11, 2018.

Annotation approved by PPC: March 10, 2018.

Suggested citation: American Diabetes Association. 8. Pharmacologic approaches to glycemic treatment: Standards of Medical Care in Diabetes—2018 [web annotation]. Diabetes Care 2018;41(Suppl. 1):S73–S85. Retrieved from https://hyp.is/1LVY-jwpEeiYsffMyzm1HQ/care.diabetesjournals.org/content/41/Supplement_1/S73.

Table 8.2 to include semaglutide

In December 2017, the U.S. FDA approved the GLP-1 receptor agonist semaglutide as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes.

Reference:

U.S. Food & Drug Administration. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&applno=209637. Accessed January 1, 2018

Rationale/Reason for Change: Approval of new treatments (medications or devices) has the potential to impact patient care.

Annotation published April 11, 2018.

Annotation approved by PPC: March 10, 2018.

Suggested citation: American Diabetes Association. 8. Pharmacologic approaches to glycemic treatment: Standards of Medical Care in Diabetes—2018 [web annotation]. Diabetes Care 2018;41(Suppl. 1):S73–S85. Retrieved from https://hyp.is/D0tVED2WEeiK8ZvLIDyLZg/care.diabetesjournals.org/content/41/Supplement_1/S73.

Table 8.2 to include ertugliflozin

In December 2017, the U.S. Food and Drug Administration approved the SGLT2 inhibitor ertugliflozin as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes.

Reference:

U.S. Food and Drug Administration. Drugs@FDA: FDA Approved Drug Products. Available from https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&applno=209803. Accessed 1 January 2018

Rationale/Reason for Change: Approval of new treatments (medications or devices) has the potential to impact patient care.

Annotation published April 11, 2018.

Annotation approved by PPC: March 10, 2018.

Suggested citation: American Diabetes Association. 8. Pharmacologic approaches to glycemic treatment: Standards of Medical Care in Diabetes—2018 [web annotation]. Diabetes Care 2018;41(Suppl. 1):S73–S85. Retrieved from https://hyp.is/8Qjypj2VEei_E2-Ft0MSjQ/care.diabetesjournals.org/content/41/Supplement_1/S73.

This is true if the product was manufactured to a consistent standard. It was found that this was not the case.

A history of good manufacturing processes does not speak to the current quality of that process. The fact is that it has been found that this process is no longer as good as it used to be.

As of 27 January 2017, and despite a request from the FDA, Hylands have refused to recall the product: https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm538684.htm

This is an unreferenced claim, but it assumes that the quantity of Belladonna alkaloids are as stated on the label.

In their laboratory analysis of 474 tablets of this product, the FDA detected the Scopolamine alkaloid in 174 of them (36.7%). The quantity in 45 of these 174 was 'Below Limit of Quantification', but the others (n=129) had quantities from 0.1 μg to 53.4 μg, a variation of 534 to 1.

https://www.fda.gov/ForConsumers/ConsumerUpdates/ucm230762.htm

While this item is included the manufacturing process of Homeopathy should remove any useful amount of it from the end product. Hyland’s Teething Tablets offer no relief from the redness, inflammation and discomfort from this ingredient.

Also; this: https://www.fda.gov/ForConsumers/ConsumerUpdates/ucm230762.htm

How is Acceptable Daily Intake calculated by FDA