The hottest FDA Regulations Substack posts right now

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Covid-19 vaccines, what just happened at the FDA, and why it matters

Your Local Epidemiologist • 3078 implied HN points • 21 May 25
🏥 Health Politics Vaccine Policy Public Health Epidemiology FDA Regulations
  1. The FDA has changed Covid-19 vaccine guidelines, now recommending them only for people over 65 or those with chronic conditions. This means younger, healthy adults might not get access to vaccines soon.
  2. Normally, big health decisions follow a clear process involving many experts and public discussions. But this recent change was made by just a few appointed officials without involving the usual expert groups.
  3. Many believe this new approach is worrying because it skips the detailed, evidence-based discussions that are important for public health decisions.

URGENT: The FDA will reject future Covid jabs for healthy people under 65 without big new clinical trials proving they work

Unreported Truths • 57 implied HN points • 20 May 25
🏥 Health Politics Public Health Vaccination FDA Regulations Chronic Conditions Health Policy
  1. The FDA now requires new clinical trials to approve Covid vaccines for healthy people under 65. This means companies must prove the vaccines are effective before they can be used.
  2. Many adults may still qualify for boosters because of loose CDC guidelines on who is at risk for severe Covid. This could allow a lot of people to continue getting the vaccine even with new rules.
  3. While this is a step towards more safety with mRNA vaccines, the rules aren’t strict enough to significantly change access for most healthy adults.

Marty Makary: Is the First Good Pick for FDA commissioner in a long time

Vinay Prasad's Observations and Thoughts • 380 implied HN points • 23 Nov 24
🇺🇸 U.S. Politics Health Policy Media bias FDA Regulations Public Health COVID-19
  1. Marty Makary is seen as a strong candidate for FDA commissioner with a history of standing up against corporate interests in healthcare. He's known for questioning common government policies during COVID, advocating for decisions based on evidence.
  2. Media coverage tends to portray Marty negatively, often ignoring his valid criticisms of lockdowns and vaccine mandates. His positions centered on protecting the vulnerable and ensuring informed consent are highlighted.
  3. Marty has a reputation for being open-minded and thoughtful in his approach to medicine. He aims to improve healthcare systems and make them more accessible, which is appreciated by some of his colleagues.

TGIF: Nutrition & Health News

Unsettled Science • 675 implied HN points • 08 Mar 24
🏥 Health & Wellness Nutrition Health News Diabetes Obesity FDA Regulations
  1. FDA approved an over-the-counter glucose monitor, making it easier for people to track blood sugar levels, important for weight loss and managing diabetes
  2. Labrador retrievers with a specific gene mutation struggle with obesity, showing lower metabolic rate and greater hunger, shedding light on genetic factors affecting weight
  3. FDA permitted a qualified health claim that yogurt 'may' prevent type 2 diabetes, based on limited scientific evidence, raising concerns about potential health risks of promoting foods high in added sugars

Book review: "Innovation Breakdown"

More is Different • 3 implied HN points • 29 Jun 23
🏥 Health & Wellness FDA Regulations Patient Safety Regulatory Challenges Healthcare Technology
  1. Innovation Breakdown tells the story of a startup harmed by FDA actions, highlighting the challenges of bringing a new medical device through the FDA.
  2. Medical device approvals at the FDA involve complex processes with regulatory uncertainties and the potential for regulatory roadblocks.
  3. The book raises questions about regulatory transparency, advocating for policy reforms to speed up approvals, reduce uncertainty, and balance strictness and effectiveness testing.
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