Showing posts with label FDA. Show all posts
Showing posts with label FDA. Show all posts

Wednesday, October 11, 2023

Take part in a MRN Clinical Trial to build the repository & earn some compensation (audio)

FM #1073 = This is the Franklin Matters radio show, number 1073 in the series. 


This shares my interview and discussion with MRN Diagnostics CEO Dr. Greg Chiklis. Our discussion was conducted on site at the MRN facility in the Forge Park Industrial Park.


  • What is MRN’s mission? The role of the MRN’s Clinical Research Division 

  • About the clinical research studies that are currently available (Ageros, Leidos)

    • Studies are handled by an experienced team of clinical coordinators who follow stringent protocols to ensure the safety of our donors and the integrity of our studies

    • Donors will receive compensation for each study that they participate in

  • Create the Biorepository for future studies

  • How we can get involved in one or more of these clinical collections

    • For more information on how you can take part, please contact us at (508) 384-0033 or email collections@mrndx.com


The recording runs about 36 minutes, so let’s listen to my conversation with Dr. Greg Chiklis. Audio link -> https://franklin-ma-matters.captivate.fm/episode/fm-1073-mrn-diagnostics-dr-greg-chiklis-10-05-23



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Home page for MRD -> https://www.mrndx.com/ 


Clinical Collections Flyer -> https://drive.google.com/file/d/1PYwt2IFAnf6TYSQKQLyAWQZZDWPw87GL/view?usp=drive_link


How to donate to one of the collections -> https://www.mrndx.com/donor-home 


Clinical Compensation summary -> https://drive.google.com/file/d/1GBAv27U-0aGb7K5jAtnc2xchHBVHs8EU/view?usp=drive_link


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We are now producing this in collaboration with Franklin.TV and Franklin Public Radio (wfpr.fm) or 102.9 on the Franklin area radio dial.  


This podcast is my public service effort for Franklin but we can't do it alone. We can always use your help.

 

How can you help?

  • If you can use the information that you find here, please tell your friends and neighbors

  • If you don't like something here, please let me know


Through this feedback loop we can continue to make improvements. I thank you for listening.


For additional information, please visit franklin.news/ or Franklinmatters.org/

If you have questions or comments you can reach me directly at shersteve @ gmail dot com


The music for the intro and exit was provided by Michael Clark and the group "East of Shirley". The piece is titled "Ernesto, manana"  c. Michael Clark & Tintype Tunes, 2008 and used with their permission.


I hope you enjoy!

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You can also subscribe and listen to Franklin Matters audio on iTunes or your favorite podcast app; search in "podcasts" for "Franklin Matters"




Wednesday, September 13, 2023

Updated COVID-19 vaccines for adults and children have just been authorized and recommended

"NEW: Updated COVID-19 vaccines for adults and children have just been authorized and recommended.

This means immunizations for all three major fall and winter respiratory viruses – COVID-19, flu, and RSV – are available.

Learn more at https://t.co/S2DQV6MlBv"
Shared from ->  https://t.co/Rc34cBzbq6

Updated COVID-19 vaccines for adults and children have just been authorized and recommended
Updated COVID-19 vaccines for adults and children have just been authorized and recommended

Thursday, April 20, 2023

CDC simplifies COVID-19 vaccine recommendations, allows older adults and immunocompromised adults to get second dose of the updated vaccine | CDC Online Newsroom | CDC

Based upon the FDA actions announced in this release, the CDC has updated their guidance as well.

"Today, the U.S. Food and Drug Administration 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 action 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, including for an additional dose or doses for certain populations. The monovalent Moderna and Pfizer-BioNTech COVID-19 vaccines are no longer authorized for use in the United States."
Continue reading for the FDA details ->
https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-authorizes-changes-simplify-use-bivalent-mrna-covid-19-vaccines


"Following FDA regulatory action, CDC has taken steps to simplify COVID-19 vaccine recommendations and allow more flexibility for people at higher risk who want the option of added protection from additional COVID-19 vaccine doses.

CDC’s Advisory Committee on Immunization Practices (ACIP) met today to discuss these COVID-19 vaccine recommendation changes, and the associated implications and implementation. Although there was no vote at this meeting, ACIP members expressed their support for these recommendations."

Continue reading for the CDC details ->
https://www.cdc.gov/media/releases/2023/s0419-covid-vaccines.html

CDC simplifies COVID-19 vaccine recommendations
CDC simplifies COVID-19 vaccine recommendations


Thursday, August 5, 2021

Celebrate National Farmers Market Week

"National Farmers Market Week kicked off on Aug. 1. It’s an annual celebration launched in 1999 by the US Department of Agriculture to call attention to the benefits of farmers’ markets and their contribution to the community. 
From sweet corn to tomatoes and raspberries picked that day, the markets offer us a host of seasonal, local foods and generate revenue for family farmers by selling directly to shoppers. Food producers — cheese and pasta makers, bakers, condiment creators, and others — benefit, too, by the direct sales. 
“Farmers’ markets bring us access not only to nutritional foods, but also preserves farmland and puts money in the local economy,” says Hal Shubin, who helps run the Belmont Farmers’ Market. Customers may grumble that the foods are costlier than at supermarkets, and some are, although plenty are competitively priced. Everything is fresher, which contributes to a longer shelf life. 
And the markets are a place where you see your friends and neighbors. The celebratory week brings special events, music, games for kids, giveaways, lectures, and more. To find a farmers’ market near you, visit massfarmersmarkets.org/markets."
Continue reading the article online (subscription maybe required) 
https://www.bostonglobe.com/2021/07/30/lifestyle/national-farmers-market-week-kicks-off-sunday/

For the events scheduled for the Franklin Farmers Market this Friday

Farmer Nick will have his tractor on the Town Common Friday
Farmer Nick will have his tractor on the Town Common Friday


More from the US Dept. of Agriculture on National Farmers Market Week

Thursday, July 22, 2021

FDA: "Recall of Certain Muffin Products Due to Possible Health Risk"

"The Food and Drug Administration (FDA) and Give & Go Prepared Foods Corp. on Monday announced a voluntary recall of 26 muffin and muffin-related products available nationwide over concerns of possible listeria contamination.

An environmental monitoring program alerted the company to the potential problem with the items, which are  sold in Walmart, 7-Eleven, Stop & Shop and other stores.

A list of all the recalled products, which include muffins packaged under labels such The Worthy Crumb and Uncle Wally's, can be found on the FDA's website. "


For the product listing provided by the FDA

FDA: "Recall of Certain Muffin Products Due to Possible Health Risk"
FDA: "Recall of Certain Muffin Products Due to Possible Health Risk"


Saturday, August 29, 2020

In the News: "the position is typically held by FDA civil servants, not political appointees"

 From the Milford Daily News, articles of interest for Franklin: 

"The credibility of two of the nation’s leading public health agencies was under fire this week after controversial decisions that outside experts said smacked of political pressure from President Donald Trump as he attempts to move past the devastating toll of the coronavirus ahead of the November election. 
The head of the Food and Drug Administration grossly misstated, then corrected, claims about the life-saving power of a plasma therapy for COVID-19 authorized by his agency. Then the Centers for Disease Control and Prevention quietly updated its guidelines to suggest fewer Americans need to get tested for coronavirus, sparking outrage from scientists. 
Trump’s own factual misstatements about COVID-19 are well documented, but the back-to-back messaging blunders by public health officials could create new damage, eroding public trust in front-line agencies. That’s already raising concerns about whether the administration will be forthcoming with critical details about upcoming vaccines needed to defeat the pandemic. 
“I do worry about the credibility of the FDA and CDC, especially at a time when the capacity of the federal government to advance public health should be a priority for all policymakers,” said Daniel Levinson, former longtime inspector general of the Department of Health and Human Services, which oversees both the FDA and the CDC."
Continue reading the article online (subscription may be required)

 

Please find links to current information regarding the COVID-19 outbreak from State and Federal agencies
Please find links to current information regarding the COVID-19 outbreak from State and Federal agencies

Wednesday, July 29, 2020

"The agency says in most cases, methanol does not appear on the product label"

From the Milford Daily News, articles of interest for Franklin:

"The Food and Drug Administration issued another warning Monday to not use certain hand sanitizers that may contain methanol or wood alcohol, a toxic substance when absorbed through skin or ingested. 
The FDA is continuing to update its “do-not-use list of dangerous hand sanitizer products,” which included 87 varieties of hand sanitizer (https://www.fda.gov/drugs/drug-safety-and-availability/fda-updates-hand-sanitizers-methanolthat should be avoided, some which have already been recalled, and other products being recommended for recalls as they may contain the potentially fatal ingredient. 
“Practicing good hand hygiene, which includes using alcohol-based hand sanitizer if soap and water are not readily available, is an important public health tool for all Americans to employ,” FDA Commissioner Stephen M. Hahn said in a statement. “Consumers must also be vigilant about which hand sanitizers they use, and for their health and safety we urge consumers to immediately stop using all hand sanitizers on the FDA’s list of dangerous hand sanitizer products.” 
In the new warning, the FDA says it is “urging consumers not to use any hand sanitizer products from the particular manufacturers on the list even if the product or particular lot number are not listed since some manufacturers are recalling only certain – but not all – of their hand sanitizer products.”
Continue reading the article online (subscription may be required)
https://www.milforddailynews.com/news/20200728/there-are-15-more-hand-sanitizers-to-watch-out-for-fda-issues-new-warning-to-avoid-nearly-90-hand-sanitizers-that-may-contain-methanol?rssfeed=true

"The agency says in most cases, methanol does not appear on the product label"
"The agency says in most cases, methanol does not appear on the product label"

Tuesday, April 28, 2020

Board of Health approves mandate for face coverings for employees of essential businesses

I took my notes with Twitter to capture the gist of what was happening at the Board of Health meeting, Monday, April 27, 2020. The meeting had two agenda items. The agenda doc can be found linked below.

Effectively, the Board of Health approved a mandate for employees of essential businesses to wear facial coverings and to reinforce the advisory that residents should wear facial coverings when visiting retail establishments. This is an interim step to be effective 4/29. There is another meeting to be scheduled for next week as a follow up and to review a new item that came up during the meeting (a clarification on golf per Governor's revised statement).

My Twitter notes were all tagged as #boh0427. As I went from this meeting to the Economic Development meeting (which had started at 5:50) I made a few mistakes by tagging some of the EDC notes with this same #boh0427 tag instead of #edc0427 - oops.

The individual tweets can be found with this search result:  
https://twitter.com/search?q=%23boh0427&src=typed_query

  • Real time reporting underway for Board of Health mtg
  • New guidelines from Attorney General referenced. Consider mandate for employees of essential business to do so as a step. Reserve N95 for health and first responders
  • Some of the citizen complaints to the Health Dept are around lack of grocery store employees not wearing cloth coverings (mask) #boh0427 . Health Director prefers advisory rather than mandate
  • Concerns expressed about the mental health of the residents as we won't be observing the smiles of neighbors. Fear of going out because people are observed wearing masks.
  • New FDA update on masks and types of just came out today. Mandate for employees, suggestion for residents to be clear. No single metric is perfect for effective of enforcement
  • Questions and discussion around enforcement, in some cases would need to be by the retail business, BoH not wanting to get Franklin Police involved, they have other and better things to do
  • Motion to adopt mandate for employees of essential business, recommended for posting of residents recommended to wear, motion approved; discussion on what effective date #boh0427 by close of business by April 29, notification coming, approved 3-0
  • Hopefully the incremental approach will bring results, if not we can go further
  • Discussion on expanding items for sale by restaurants and essential business, modify temp food permit to provide the steps/guidance for the business to do so. #boh0427 Health Director to come up with listing of items
  • Motion for food establishments to sell grocery items, approved by 3-0 vote. Golf question came up in chat, can't add to this agenda. Will consider for next week meeting TBD #boh0427 motion to adjourn, passed via roll call

The new FDA update on masks as mentioned during the meeting is found here
https://drive.google.com/file/d/1bckh-j1LwwNztxa52Jdsk4K5fVQALY_G/view?usp=sharing






screengrab of Zoom meeting early in the meeting
screengrab of Zoom meeting early in the meeting

Wednesday, July 24, 2019

FDA announce first youth e-cigarette prevention (YouTube)


announced their first youth e-cigarette prevention TV ads & new posters w/ e-cigarette prevention messaging for high schoolers. Learn more about the ways
is working to stop the youth e-cigarette epidemic. #NoEcigs4Kids"
Found via Twitter

https://youtu.be/xw1vffiNyVM