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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

[ Price : $8.95]

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

Recall Ready Guidance Out

[ Price : $8.95]

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

[ Price : $8.95]

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

Device, Drug Recalls Down in 2021: Sedgwick

[ Price : $8.95]

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

[ Price : $8.95]

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

Info Collection Extension on Emergency Use Authorization

[ Price : $8.95]

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

Trial Results Unlikely to Support sNDA Approval: FDA

[ Price : $8.95]

FDA tells Karyopharm clinical trial results are unlikely to support approval of its selinexor as maintenance therapy for endometri...