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FDA Reclassifies Shortwave Diathermy

[ Price : $8.95]

Federal Register Final order: FDA reclassifies shortwave diathermy for all other uses into Class 2 and renames the device.

FDA Clears NuVasive X-Core Cervical Corpectomy Device

[ Price : $8.95]

FDA clears a NuVasive 510(k) for its X-Core Mini Cervical Corpectomy System, an expandable titanium vertebral body replacement dev...

Cook Medical Expands Recall of Angiographic Catheters

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Cook Medical expands an earlier recall to include select sizes of its Beacon Tip Angiographic Catheters because the devices have b...

FDA Breakthrough Status for Rebiotix C Diff Candidate

[ Price : $8.95]

FDA grants a breakthrough therapy designation request to Rebiotix for its Microbiota Restoration Therapy (MRT) RBX2660 for treatin...

Rare Disease Fund Act of 2015 Introduced in House

[ Price : $8.95]

Representatives Thomas J. Rooney (R-FL) and Juan Vargas (D-CA) introduce the Rare Disease Fund Act of 2015 that seeks to act as a ...

Comments Sought on Info in DTC Ads

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Federal Register Notice: FDA seeks comments on research on quantitative information in direct-to-consumer television advertisement...

FDA Withdraws 67 NDAs, 128 ANDAs

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Federal Register Notice: FDA withdraws approval of 67 NDAs and 128 ANDAs that are no longer marketed.

FDA Approves Endologix AFX2 Endograft System

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FDA approves an Endologix PMA for its AFX 2 Bifurcated Endograft System for treating abdominal aortic aneurysms.

FDA Posts Recent NADA, ANADA Actions

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Federal Register Final rule: FDA amends its animal drug regulations to reflect July-August actions related to NADAs and ANADAs and...

FDA Withdraws Approval of Zoetis NADA

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Federal Register Notice: FDA withdraws approval of a Zoetis NADA for using penicillin G procaine in poultry and swine feed.