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Development and external validation of the FluScoreVax risk score for influenza that incorporates vaccine status (EAST-PC) [Acute respiratory infections]

Annals of Family Medicine

Objective: To develop and externally validate a simple risk score for influenza diagnosis based only on vaccination history and patient-reported symptoms. Results: We developed a risk score with 6 items (subjective fever, interfered with usual activity, headache, wheeze, phlegm, and recent flu vaccine) and a range from -5 to 6 points.

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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

The Tropical Disease PRV program was born the very next year as part of the Food and Drug Administration Amendments Act of 2007 (FDAAA) and expanded in 2014 , which experts heralded as a game-changer for tropical disease therapies. Below, we discuss some of its downstream impacts on the PRV landscape.

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FDA-Approved Labeling: Is Enough Enough?

FDA Law Blog

FDA did, however, try to identify safety issues through the medical literature and (after 2007 when mandatory safety reporting for OTC human drug products marketed without an approved application became effective) through the adverse event reporting system. Koblitz & Deborah L. More than a few have taken far longer—literally decades.

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What RFK Jr. Isn’t Talking About: How To Make Vaccines Safer

Physician's Weekly

Within an hour of receiving a covid vaccination in November 2020, Utah preschool teacher Brianne Dressen felt pins and needles through her arms and legs. While it’s possible that Nath’s patients suffered covid vaccine injuries, Marks said, their symptoms were so varied it was hard to characterize a possible syndrome.