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Jubilant Generics Cited Over GMPs

[ Price : $8.95]

FDA issues Jubilant Generics a four-observation Form FDA-483 after inspecting the firms India facility in February.

AbbVie Urges FDA to Ban Unlicensed Thyroid Products

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AbbVie petitions FDA urging it to crack down on newly introduced unlicensed desiccated thyroid extract products.

FDA Seeks Industry Rep for Device Panel

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Federal Register notice: FDA seeks industry organizations interested in participating in selecting a nonvoting industry representa...

Panel to Discuss Pediatric Studies for Cancer Drugs

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Federal Register notice: FDA announces a 5/22 Pediatric Oncology Subcommittee of the Oncologic Drugs Advisory Committee meeting to...

Withdraw AvertD Approval: Scientists

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Some 31 experts in genetics, addiction, psychiatry, and medical devices call on FDA to revoke its approval of the AvertD DNA test ...

45 CDRH Safety Communications in 2022: Report

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In a delayed report to Congress, CDRH says it issued 45 medical device safety communications of various types in 2022.

Medos Guide Sheath Recall is Class 1: FDA

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FDA says the Medos International Srl recall of the Cerenovus Cerebase DA guide sheath is Class 1.

Liquidia Expects FDA Yutrepia Final OK Soon

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Liquidia says it believes there no longer are legal bars on FDA approving its Yutrepia inhalation powder for two indications.

Novartis Seeking Expanded Pluvicto Label

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Novartis says it will seek FDA approval for an expanded use for Pluvicto (lutetium Lu 177 vipivotide tetraxetan) for slowing disea...

FDA Cross-Center AI Paper Analyzed

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Hogan Lovells attorneys say FDA may create new Centers of Excellence as it works to regulate AI in medical product development thr...