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Sometimes, Should FDA Consider Product Cost?

[ Price : $8.95]

FDA Matters author Steven Grossman argues that in some cases FDA should consider the cost difference between an expensive product ...

FDA Clears Nucletron's Brachytherapy Device

[ Price : $8.95]

FDA clears a Nucletron 510(k) clearance for its new Vaginal CT/MR Multi Channel Applicator, a brachytherapy solution that enables ...

FDA, AdventRx Meet on Rejected Bio Study

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AdventRx says a recent meeting with FDA on an August complete response letter for Exelbine (vinorelbine injectable emulsion) conf...

Chembio Diagnostics PMA Module for HIV Test

[ Price : $8.95]

Chembio Diagnostics files a second PMA module for its DPP HIV 1/2 Assay which contains non-clinical data for the product.

FDA OKs Ivy Labs sANADA for Heifer Feed

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Federal Register Final rule: FDA approves an Ivy Labs sANADA for increased dose levels of melengestrol acetate and monensin in med...

Circadian Technologies IND for Cancer Therapy Add-on

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Circadian Technologies submits an IND application to initiate clinical studies involving VGX-100 for treating a variety of differe...

Want to Save Thousands of Lives, Dr. Hamburg?

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Washington commentator Robert F. Steeves challenges commissioner Hamburg to take two easy steps that he says would save thousands ...

Guidance on Media Fills/Process Simulations for PET Drugs

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Federal Register Notice: FDA releases a draft guidance on media fills for validation of aseptic preparations for positron emission...

Mammography Quality Assurance Panel to Meet

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Federal Register Notice: FDAs National Mammography Quality Assurance Advisory Committee will meet 11/4 to discuss among other topi...

CDRH Revamps De Novo Device Reviews

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CDRH releases an anticipated draft guidance for device makers that updates and streamlines the de novo review process used for cer...