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Median Seeks FDA Input on iBiopsy Regulatory Pathway

[ Price : $8.95]

Median Technologies files a 513(g) submission seeking FDA guidance on the best path to market for its iBiopsy Lung Cancer Screenin...

Circa Scientific Esophageal Temperature Probe Cleared

[ Price : $8.95]

FDA clears a Circa Scientific 510(k) for its S-CATH M Esophageal Temperature Probe which can be visualized on 3D cardiac mapping s...

Civica Planning for Affordable Insulins

[ Price : $8.95]

Civica says it will develop and manufacture three insulin biosimilars to be sold at a lower price than current products.

Navarro Debarred Over Study Fabrications

[ Price : $8.95]

Federal Register notice: FDA permanently debars Eduardo Navarro from providing services related to an approved or pending drug pro...

4 Information Collections Approved by OMB

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Federal Register notice: FDA posts four recent information collections that have been approved by OMB.

Recall Ready Guidance Out

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FDA publishes a guidance to help companies be ready to quickly and effectively remove recalled products from the market.

Questions Raised Again About Accelerated Approvals

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The Los Angeles Times raises concerns about FDAs use of accelerated approval pathways for many new drugs.

Device, Drug Recalls Down in 2021: Sedgwick

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The Sedgwick recall index for 2021 shows that both medical devices and drugs had fewer recalls and the recalls involved more units...

FDA 2021 Personalized Medicine Milestones

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The Personalized Medicine Coalition says FDA is accelerating its involvement in personalized medicine.

Info Collection Extension on Emergency Use Authorization

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Federal Register notice: FDA seeks comments on an information collection extension entitled Emergency Use Authorization of Medical...