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Human Drugs

Immusist Selling Unapproved, Misbranded New Drugs

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

FDA General

FDA Resisting Civil Service Executive Order: Report

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

Biologics

Young Center Illegally Marketing Stem Cell Product: FDA

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

Medical Devices

FDA Caution on Covid Antigen Test False Positives

FDA reminds laboratories and healthcare providers that false positives can occur with antigen tests being used for the rapid detection of SARS-CoV-2.

Human Drugs

FDA OKs Endari Updated Prescribing Info

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

FDA General

Consider Making FDA Independent: Law School Professor

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

Federal Register

FDA Service Delivery Feedback Info Collection Extension

Federal Register notice: FDA sends to OMB an information collection extension for Generic Clearance for the Collection of Qualitative Feedback on Agen...

Federal Register

Info Extension on Strategic Stockpile Labeling

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

FDA General

Latest FDA Warning Letters

FDA releases its latest batch of Warning Letters that include Cosmax USA and Immusist LLC.

Human Drugs

Salix Gets Orphan Status for Sickle Cell Drug

FDA grants Salix Pharmaceuticals an orphan drug designation for rifaximin and its use in treating sickle cell disease.