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Nominations Sought for Patient Engagement Panel

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Federal Register notice: FDA requests nominations for voting members, excluding consumer and industry representatives, to serve on...

Meeting on User Fee Program Financials

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Federal Register notice: FDA announces a 6/6 public meeting entitled Financial Transparency and Efficiency of the Prescription Dru...

24 Drugs Not Withdrawn Due to Safety/Efficacy

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Federal Register notice: FDA determines that 24 listed drug products were not withdrawn from sale for reasons of safety or effecti...

De Novo for Antibacterial Coated Implants

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FDA grants Onkos Surgical a de novo marketing authorization for its novel antibacterial coated implants.

Shuffert Debarred for 5 Years

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Federal Register notice: FDA issues an order to debar for five years Robert Lance Shuffert from importing or offering for import a...

Abecma Expanded Approval for Multiple Myeloma

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FDA approves a Bristol Myers Squibb and 2Seventy Bio supplemental BLA for Abecma (idecabtagene vicleucel; ide-cel) for treating ce...

Honeywell Recalls Eyewash Cartridge

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Honeywell Safety Products recalls its Fendall 2000 Non-Sterile Eyewash Cartridge for the Fendall 2000 Eyewash Station due to GMP c...

Accelerated Approval for Enhertu in Solid Tumors

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FDA grants Daiichi Sankyo an accelerated approval for Enhertu (fam-trastuzumab deruxtecan-nxki) for treating certain adult patient...

Jubilant Generics Cited Over GMPs

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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.