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ViiV Dovato Ad Claims Challenged

The Better Business Bureaus National Advertising Division refers to FDA and the Federal Trade Commission for review and possible enforcement action di...

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Drug Supply Chain Independence Bill

Bipartisan legislation is reintroduced in the House that its sponsors say will make the nations pharmaceutical supply chain less dependent on foreign ...

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Medical Devices

Ultromics Gets Breakthrough Status for AI Device

FDA grants Ultromics a breakthrough device designation for its artificial intelligence-supported platform for detecting cardiac amyloidosis.

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Medical Devices

Cybersecurity Alert on Illumina Device Software

FDA issues an alert about a cybersecurity vulnerability affecting the Universal Copy Service software in several Illumina laboratory instruments.

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Human Drugs

FDA Approves Oral Fecal Microbiota Capsules

FDA approves a Seres Therapeutics BLA for Vowst (fecal microbiota spores, live-brpk), an orally administered microbiota-based product to prevent recur...

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Human Drugs

Prevent Makena Compounding: Public Citizen

Public Citizen calls on FDA to promptly add Covis Pharmas Makena to the official list of drugs that have been withdrawn for reasons of safety or effec...

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Federal Register

Info Collection on Animal Drug Reporting

Federal Register notice: FDA sends to OMB an information collection entitled Records and Reports Concerning Experiences with Approved New Animal Drugs...

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Human Drugs

Gillibrand Bill to Speed FDA Approval of Some Drugs

Sen. Kirsten Gillibrand introduces the bipartisan Promising Pathways Act to permit FDA provisional approval of some drugs for life-threatening disease...

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Human Drugs

Quality Management Maturity Dividing Industry: PDA

The Parenteral Drug Association says its members still have many questions about CDERs Quality Management Maturity program and recommendations to impr...

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Human Drugs

FDA Clears 2 Wound Dressings from 3M Health

FDA clears two 510(k)s from 3M Health Care for its 3M Veraflo Cleanse Choice Complete Dressing and 3M VAC Veraflo Cleanse Choice Dressing.