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Floridas FDA-Authorized Canadian Drug Import Program Stalls

[ Price : $8.95]

Floridas FDA-authorized drug importation program stalls and has yet to deliver any imported medicines more than two years after re...

Warning Letter Sent to Beta Bionics

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FDA issues Beta Bionics a Warning Letter following an inspection of the companys Irvine, CA, facility conducted 6/2025.

Aquestives Epinephrine Film Gets Complete Response

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FDA sends Aquestive Therapeutics a complete response letter for its NDA for Anaphylm, a sublingual epinephrine film for treating T...

FDA Launches PreCheck Drug Manufacturing Pilot

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FDA launches its new PreCheck pilot program aimed at strengthening domestic pharmaceutical manufacturing by providing earlier regu...

Citizen Petition Seeks Database for Medical Device Labels

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A patient safety advocacy group files a citizen petition urging FDA to create a comprehensive public database of medical device la...

$17.9 Million Settlement in Generic Drug Price-Fixing Case

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New York Attorney General Letitia James and a bipartisan coalition of 47 other attorneys general secure $17.85 million from drug m...

FDA Accepts Exelixis NDA for Metastatic Colorectal Cancer

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FDA accepts for review an Exelixis NDA for zanzalintinib in combination with the immune checkpoint inhibitor atezolizumab for pati...

Complete Response on Pharmings Pediatric sNDA for Joenja

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FDA issues Pharming Group a complete response letter for its supplemental NDA seeking expanded approval of Joenja (leniolisib) for...

FDA Updates Device Inspection Program Due to QMSR Move

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FDA discontinues the use of its Quality System Inspection Technique for medical device inspections and will instead conduct inspec...

Grail Submits Final PMA Module for Cancer Blood Test

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Grail files the final module of its PMA for the companys multi-cancer early detection blood test.