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Recent items include:
- <![CDATA[What Moments in FDA’s Review Process Should Patients and Providers be Watching Closely?]]>
- <![CDATA[Your Questions Answered: Two FDA Approvals, Six Platform Deals, and a European Warning]]>
- <![CDATA[Pharmaceutical Executive Daily: FDA Approves Onswik]]>
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<![CDATA[Your Questions Answered: Two FDA Approvals, Six Platform Deals, and a European Warning]]>
<![CDATA[Pharmaceutical Executive Daily: FDA Approves Onswik]]>
The paperwork problem: How many FDA warning letters actually cite document failures
When people take a medication, they trust that it contains the right amount of active ingredient and is free of harmful contamination. Manufacturing and test records help verify th...
MedWatch: Τι αποκαλύπτουν 13.712 «ύποπτα» ευρήματα για δομές Υγείας
Το «ψηφιακό ραντάρ» σαρώνει το Διαδίκτυο εντοπίζοντας πρακτικές που μπαίνουν στο μικροσκόπιο των ελεγκτικών αρχών – Τι δείχνουν τα νεότερα στοιχεία σε Αθήνα, Πειραιά και Θεσσαλονίκ...
FDA adds boxed warning to Injectafer for hypophosphatemia risk
The FDA added a boxed warning detailing the known risk for symptomatic hypophosphatemia associated with ferric carboxymaltose injection, according to an agency press release.The bo...
Health Ministry approves biovigilance programme to monitor adverse drug reactions
The programme will focus on reporting, assessment, monitoring and prevention of adverse events associated with medicines and biological products used in organ and tissue transplant
<![CDATA[Pharmaceutical Executive Daily: FDA Approves Fayuvi]]>
<![CDATA[FDA Approves Lisraya for Adults with Dermatomyositis, Bixlenvo for Virologically Suppressed Adults with HIV,...
Supplements dominate cross-border alerts in Europe
Twenty alerts mentioned the United States
Nutromics Nabs FDA Breakthrough Status for Antibiotic Monitoring Patch
Nutromics earned FDA breakthrough device designation for its wearable patch that tracks vancomycin levels in real time. The device aims to replace the periodic blood draws currentl...
MOPH Warns Against Use of Gastrozero Over Undeclared Drug Ingredients
The Ministry of Public Health (MOPH) has warned against using Gastrozero, an unlicensed dietary supplement containing undeclared pharmaceutical ingredients that could pose a risk t...
<![CDATA[ClaimGuardRx Gives Account Teams Instant Answers on Diversion and Fraud]]>
Healthcare Company Recalls Multiple Injectables: See Affected Drugs
The FDA warns that contaminated products may cause blood clots or organ damage, and some supplies could be sitting in home health settings
FDA issues warning letters after contaminated product harms horses
Fungal contamination in topical wound care solution linked to serious infections in nearly 100 horses, at least 20 of which had to be euthanized.
This Amazon Brand of Medication Is Being Recalled. See the Affected Drug
Discolored tablets triggered a recall of more than 112,000 bottles, and the FDA hasn't yet rated the health risk — check your lot number.
<![CDATA[Pharmaceutical Executive Daily: FDA Approves Zanvastro]]>
FDA Warns of Contamination in Veterinary Product HYCOAT
The FDA issues warning letters to Neogen Corporation and Sciarra Aeromed following an investigation that linked a veterinary wound care product labeled as sterile, Neogen Vet HYCOA...
Injectable Drugs Sold Nationwide Recalled. See Affected Medications
The recall covers 10 lots distributed through Sept. 21; the FDA warns injected endotoxins can trigger reactions as severe as anaphylactic shock.
Western Wildland Firefighters Warned About Supplement for Smoke Exposure
Fire and medical officials have issued warnings about a supplement offered to Western wildland firefighters who have been exposed to toxic chemicals while battling some of the coun...
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