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FDA Publishes Its Draft Strategy Document on Innovative Manufacturing Technologies

FDA Law Blog

FDA-2024-N-3945 ] announcing the publication of a draft strategy document, for public comment, outlining specific actions FDA plans to take to facilitate the use of innovative manufacturing technologies. This would include continuous manufacturing, distributed manufacturing, modern aseptic manufacturing equipment and novel analytical methods.

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Have you had your flu shot?

New South Family Medicine and MedSpa

There are formulations manufactured without egg products, so the worry of egg-allergy should not be a reason to abstain from a flu shot. Anyone with chronic illness, pregnant women, and extremes of age are more likely to be hospitalized, so we all need to do our part to keep each other safe.

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Zicam and Orajel Swabs Recalled for Possible Fungal Contamination

Physician's Weekly

Food and Drug Administration (FDA) after the manufacturer, Church & Dwight Co., So far, no illnesses or serious injuries have been reported, CBS News said. health officials said. The recall was announced by the U.S. found the problem during testing, CBS News reported. More information Read the full recall notice at the U.S.

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A Question 30 Years in the Making: Would a Final LDT Rule Withstand Judicial Scrutiny?

FDA Law Blog

Regulating LDTs: A Long and Winding Road In what might sound to some like protesting too much, the PR invokes FDA’s longstanding assertion that IVDs “manufactured” by laboratories are medical devices and that clinical laboratories that develop tests are acting as manufacturers.

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Second Circuit Agrees that Copay Assistance Programs May Violate the Anti-Kickback Statute

FDA Law Blog

Pfizer manufactures tafamidis, a breakthrough treatment for a rare, progressive heart condition known as transthyretin amyloid cardiomyopathy. After all, Lilly offered access to treatment for critically ill patients in financial need who would otherwise have to forego treatment or be saddled with a $13,000 per year copay. Background.

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Fun With Primescan and Atlantis

CDOCS

& Patient presents as an 80 year old woman who was wearing an ill fitting partial for awhile and was losing weight because eating was very difficult. & & These are my favorite types of cases, where we can really make a difference for someone. & jpg][image:Untitled_2_012.jpg]</p>

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The Future Of Vision And Eye Care

The Medical Futurist

Treating less serious ailments gets faster, more targeted and more efficient, while the means for curing more serious and life-altering illnesses improve. Here, I outlined the way technology delineates the future of eye care and vision.

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