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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. So how did we get here? There is no question the last year has been unlike any other for all of us, but FDA has been steeped in “new” too.

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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. The omitted phrase therefore provided material facts that may be relevant to prescribing veterinarians and dog owners. 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

Having Your Own Long-Term GP Can Save Your Life Patients who choose a GP rather than a specialist as their primary care provider have a 19% 8 lower mortality and produce 22% 9 -33% 8 lower healthcare spending. million people in 2018), shows that the longer you know your GP, the better off you are. Over time, communication improves.

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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. 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

Our SOAR review provides readers with a curated list of high-quality blog posts on topics of respiratory infectious disease. Prior SOAR reviews have established an rMETRIQ high-quality cutoff score of greater than or equal to 16. How can I use these findings?

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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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Podcast Episode: Febrile Seizures

PEMBlog

Common variants associated with general and MMR vaccine-related febrile seizures. 2018 Nov;142(5):e20181009. Epub 2018 Oct 8. Vaccines don’t cause autism, but they might cause febrile seizures. The absolute risk is small, and genetic susceptibility likely plays a role in seizures after vaccines. Pediatrics.

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