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Digital Health Center of Excellence Roadmap Explained

[ Price : $8.95]

An FDA Webinar listening session discusses the role and operations of the new Digital Health Center of Excellence.

Medtronic Class 1 Recall of Rashkind Balloon Catheters

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Medtronic begins a Class 1 recall of its Rashkind Balloon Septostomy Catheters because of device quality issues that may lead to t...

Immusist Selling Unapproved, Misbranded New Drugs

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FDA warns Immusist that it is selling unapproved and misbranded new drugs.

FDA Resisting Civil Service Executive Order: Report

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Politico reports that FDA and other health agencies are trying to fight an Executive Order that could make it easier for the Trump...

Young Center Illegally Marketing Stem Cell Product: FDA

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FDA warns the Young Foundational Health Center that it is illegally marketing stem cell products for a variety of diseases and con...

FDA Caution on Covid Antigen Test False Positives

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FDA reminds laboratories and healthcare providers that false positives can occur with antigen tests being used for the rapid detec...

FDA OKs Endari Updated Prescribing Info

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FDA approves updated prescribing information for Emmaus Life Sciences Endari (L-glutamine oral powder) to better inform healthcare...

Consider Making FDA Independent: Law School Professor

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Law professor Dorit Reiss outlines ways Congress could restructure FDA to make it better able to withstand political pressure on p...

FDA Service Delivery Feedback Info Collection Extension

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Federal Register notice: FDA sends to OMB an information collection extension for Generic Clearance for the Collection of Qualitat...

Info Extension on Strategic Stockpile Labeling

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Federal Register notice: FDA sends to OMB an information collection extension for Exceptions or Alternatives to Labeling Requireme...