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FDA’s Accelerated Approval of Biogen’s Aduhelm for Alzheimer’s: A Sign of Applying the Emergency Use Standard Beyond COVID?

FDA Law Blog

This sentence was included in the 2016 approval of Exondys 51 for Duchenne muscular dystrophy and the 2018 approval of Andexxa for reversal of anticoagulation therapy. This has been a decision we’ve been closely following. Key Takeaways from the Aduhelm Label: What’s in It and What Isn’t. What do we mean?

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Can the Tropical PRV Have Its Moment (Again?) – Not all Priority Review Vouchers are Created Alike: What the Potential Loss of the Rare Pediatric PRV Could Mean for the Tropical Disease PRV Program

FDA Law Blog

2014) June 2016 Vaxchora (Pax Vax Bermuda) Cholera vaccine for travelers $ 290 (June 2016) Aug 2017 Benznidazole (Chemo Research) Chagas disease UNK June 2018 Moxidectin (Medicines Devt for Global Health) Onchocerciasis, or river blindness UNK (May 2019) July 2018 Krintafel (GSK) P.

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Every Claim You Make, Every Step You Take…CVM Will Be Watching You

FDA Law Blog

Zenrelia comes with serious warnings, including a boxed warning against the use of Zenrelia during vaccination. CVM also objected to the truncation of other information about the timing of vaccines in these promotional materials. Zenrelia promotional materials also included claims about clinical data that the Agency found actionable.

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8 Reasons Why Family Physicians are the Actual Stars of Medicine

Family Medicine Initiative

million people in 2018), shows that the longer you know your GP, the better off you are. A recent study of almost 3 million US patients showed that those who visited primary care were much more likely to receive preventive services : 127% more vaccinations, 122% more colonoscopies, and 75% more mammograms. Here are the key results.

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Book Review: Booster Shots by Dr. Adam Ratner

Common Sense Family Doctor

As a measles outbreak in West Texas approaches 100 cases and the national percentage of kindergarten-age children who have received measles, mumps, and rubella (MMR) vaccine has fallen below 93% , vaccine conspiracy theory amplifier Robert F. this is it. Kennedy, Jr. has taken the reins as Secretary of Health and Human Services (HHS).

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How to Find More Quality Blog Posts on Respiratory Infections in Children: Findings from a SOAR Review

PEMBlog

Be sure to check out our previous posts on: BRONCHIOLITIS , EPIGLOTTITIS , PNEUMONIA , and CROUP The Problem: Free open access medical education (aka FOAM) is great in that it allows for asynchronous, focused learning.

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Whoop! There It Is: A Pertinent Pediatric Pertussis Podcast

PEMBlog

In this episode of PEM Currents: The Pediatric Emergency Medicine Podcast , we explore pertussis, also known as whooping cough – a disease that remains a public health challenge despite widespread vaccination efforts. Pediatr Rev May 2018; 39 (5): 247–257. Daniels, Camille Sabella; Bordetella pertussis (Pertussis).

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