The hottest FDA Regulation Substack posts right now

And their main takeaways
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FDA Commissioner Promotes Products Off Label, an Illegal Pharma Marketing Scheme Long Criticized by Democrats

The DisInformation Chronicle • 2005 implied HN points • 09 Jan 24
🏥 Health Politics FDA Regulation
  1. FDA Commissioner is promoting products off-label, which is illegal marketing scheme criticized by Democrats
  2. There are concerns about conflicts of interest in reporting on COVID vaccine efficacy
  3. Clinicians may not always see conflicts of interest when receiving payments from pharmaceutical companies

URGENT: mRNA Covid jabs should NEVER have been approved for children or young adults

Unreported Truths • 44 implied HN points • 30 Nov 25
🏥 Health Politics FDA Regulation
  1. mRNA Covid vaccines may have serious side effects for children, and these concerns were known during the trials. It's important to be aware of these risks when considering vaccination for young ones.
  2. Some deaths, including a child's, occurred during vaccine trials, but this information was not fully shared with the public for years. Transparency in clinical trials is crucial for public safety.
  3. Data presented by vaccine manufacturers wasn't always accurate, leading to misleading conclusions about their effectiveness and safety for kids. Parents should approach such information with caution.

BREAKING/EXCLUSIVE: The FDA may add a strict "black box" warning on mRNA Covid shots for kids and teens.

Unreported Truths • 42 implied HN points • 01 Dec 25
🏥 Health Politics FDA Regulation
  1. The FDA might add a serious warning to mRNA Covid vaccines for kids and teens due to a report linking the shots to deaths. This warning informs parents and doctors about the risks.
  2. The report claims that at least 10 children and teens died after receiving the vaccines. This raises questions about whether the shots are worth the potential dangers.
  3. There is a possibility that the FDA could completely stop the use of these vaccines for young people, reflecting growing concerns among parents and health officials.

Marijuana Reconsidered

In My Tribe • 789 implied HN points • 11 Jul 23
🏥 Health & Wellness FDA Regulation
  1. Marijuana legalization has not significantly reduced excessive incarceration and has increased the use of the drug.
  2. Observational studies suggest a link between chronic cannabis use and mental illnesses like schizophrenia, depression, and bipolar disorder.
  3. There should be strict regulations on marijuana use, with rigorous testing of its medicinal claims and penalties for public use and driving under the influence.

On Big Pharma's demolition of Dr. Vinay Prasad, one of the most honest people in medicine

Unreported Truths • 47 implied HN points • 31 Jul 25
🏥 Health Politics FDA Regulation
  1. Dr. Vinay Prasad was a strong advocate for the safety and efficacy of new drugs. He tried to set high standards at the FDA but was pushed out quickly because he challenged Big Pharma interests.
  2. Pharmaceutical companies often get approvals for drugs that have not proven to be effective for patients. This can put patients at risk, especially when treatments are very expensive and potentially harmful.
  3. The FDA needs to maintain strict standards to protect patients from unsafe drugs. If companies can't prove their drugs work, they shouldn't profit from them until there's real evidence of benefit.
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Pfizer's own study shows their COVID vaccines increase your risk of serious adverse events (up to 71% higher)

Steve Kirsch's newsletter • 13 implied HN points • 18 Dec 24
🏥 Health Politics FDA Regulation
  1. Pfizer's study suggests that their COVID vaccines may actually raise the risk of serious health issues by up to 71%. This information is concerning and not widely reported.
  2. The research compared vaccinated individuals with unvaccinated ones, and found notable health risks for vaccinated people, such as increased chances of heart problems and other serious conditions.
  3. Despite the alarming findings, there seems to be a lack of transparency from Pfizer and health authorities, leading some to feel that important safety information is being kept under wraps.

Who should be our next FDA Commissioner?

More is Different • 8 implied HN points • 17 Nov 24
🇺🇸 U.S. Politics FDA Regulation
  1. Dr. Joseph Gulfo believes the FDA should focus on fast-tracking safe and effective treatments instead of just protecting public health. He says this can help bring more innovative drugs to patients who need them.
  2. Balaji Srinivasan thinks the FDA's rules need to change so it can evaluate drugs and treatments better. He suggests creating new centers at universities to find smarter ways to approve medical products.
  3. Jim O'Neill has some government experience but may not be as strong as the other candidates. People are unsure about his past and whether he can lead the FDA effectively.

FDA approves first OTC CGM system

philsiarri • 0 implied HN points • 06 Mar 24
🏥 Health & Wellness FDA Regulation
  1. FDA authorized the first over-the-counter continuous glucose monitor (CGM), Dexcom Stelo Glucose Biosensor System, for individuals 18 and older not using insulin.
  2. The CGM system aims to help users understand the effects of diet and exercise on blood sugar levels, providing glucose readings every 15 minutes with sensors lasting up to 15 days.
  3. The FDA clearance for this device emphasizes increased health equity by making health monitoring more accessible, although some side effects like skin irritation and pain have been reported.