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Human Drugs

Healwell Homeo Private Selling Adulterated Drugs: FDA

FDA warns Indias Healwell Homeo Private Limited about producing adulterated homeopathic and OTC drugs with CGMP violations.

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Medical Devices

Contec and Epsimed Cybersecurity Patch

FDA says Contec has issued a software patch that resolves cybersecurity vulnerabilities in certain Contec and Epsimed patient monitors by removing net...

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Human Drugs

FDA: Website Selling Misbranded, Unapproved Drugs

FDA warns the owners of the www.buynetmeds.com Web site about selling misbranded and unapproved drug products in interstate commerce.

Medical Devices

Baxter: Remove Spectrum Infusion Pumps

FDA issues an Early Alert for a Baxter Spectrum infusion pump software issue.

Human Drugs

FDA Expands ER-Stimulant Labeling for Weight Loss

FDA orders Limitation of Use wording in labeling for extended-release stimulants used to treat ADHD to raise the risk of weight loss in children under...

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Human Drugs

Guidance on Aluminum Content in Parenteral Drugs

FDA issues a draft guidance entitled Small Volume Parenteral Drug Products and Pharmacy Bulk Packages for Parenteral Nutrition: Aluminum Content and L...

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FDA General

FDA Elsa Rollout a Nuanced Dance: Consultant

Consultant Erika Roberts says FDAs rollout of its staff AI tool Elsa is a good first step, but much more needs to be done to reach the potential of us...

Medical Devices

Sirtex Medical Wins Device OK for Liver Cancer

FDA approves a Sirtex Medical PMA for its SIR-Spheres Y-90 resin microspheres for treating unresectable hepatocellular carcinoma.

Biologics

Vacate RFK Jr. Covid Vaccine Recommendations: Lawsuit

A group of medical societies files suit against HHS secretary Robert F. Kennedy Jr. and FDA commissioner Marty Makary to reverse a 5/27 decision to re...

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FDA General

FDA WEBVIEW CLOSED JULY 4TH WEEK

In annual observance of the Fourth of July (Independence Day) holiday in the U.S., FDA Webview closes its news operations until Monday, July 7.