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Info Collection for Radiation Product Testing

[ Price : $8.95]

Federal Register notice: FDA seeks comments on an information collection extension for Testing Communications on Medical Devices a...

Generics See Mixed Results on Obtaining Samples: GAO

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A new Government Accountability Office report finds that generic drug companies are having mixed results from FDAs efforts to help...

Panel Backs Expanded Vascepa Use

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FDAs Endocrinologic and Metabolic Diseases Advisory Committee unanimously votes to recommend approval for Amarins submission to ex...

FDA Clears Safer Pentax Duodenoscope

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FDA clears a Pentax 510(k) for the first duodenoscope with a sterile, disposable elevator component that the agency says will redu...

Novartis Gains Approval for Sickle Cell Therapy

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FDA approves a Novartis BLA for Adakveo (crizanlizumab-tmca) for reducing the frequency of vaso-occlusive crisis in sickle cell di...

Shionogi Urinary Tract Infection Drug Approved

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FDA approves a Shionogi & Co. NDA for Fetroja (cefiderocol), an antibacterial drug for treating patients 18 years of age or older ...

FDA Funds Quality Management Research Project

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FDA funds a $1.7 million two-year project in which five universities will study quality management in FDA drug manufacturing opera...

Final Guide on Export Certificate Denials

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Federal Register notice: FDA makes available a final guidance entitled Process to Request a Review of FDAs Decision Not to Issue C...

Info Collection on Cardiovascular Outcome Claims Guide

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Federal Register notice: FDA sends to OMB an information collection extension for Hypertension Indication: Drug Labeling For Cardi...

Ultromics EchoGo Core Heart Scan Checker Cleared

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FDA clears an Ultromics 510(k) for its image analysis system EchoGo Core, which uses artificial intelligence to automate the analy...