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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Federal Register Notice: FDA releases a draft guidance on media fills for validation of aseptic preparations for positron emission...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CDRH releases an anticipated draft guidance for device makers that updates and streamlines the de novo review process used for cer...

FDA Clears Neo Dental Cavity Fillers

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FDA clears a Neo Dental International 510(k) for the Cavios Cavity Liner product and Evadyne Temporary Resin product.

Government Seeking More Healthcare 'Exclusions'

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FDA's Ric Blumberg and HHS' Greg Demske lay out the case for why the U.S. government has recently increased its efforts to exclude...

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...

FDA Clears Amcom Messenger

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FDA clears Amcoms Messenger middleware secondary notification system.

Comments Sought on Drug Shortages

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Federal Register Notice: FDA opens a comment period on the topic CDER addresses in a 9/26 public workshop, drug shortages.

CBER Seeks Vaccine Panel Nominations

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Federal Register Notice: FDA seeks industry organizations interested in helping select representatives for CBER Vaccines advisory ...