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Pilot Survey to Assess Allergy to Cosmetics

[ Price : $8.95]

Federal Register notice: FDA seeks comments on a new proposed information collection entitled Web-Based Pilot Survey To Assess All...

FDA Alert on Recalled Eye Drops

[ Price : $8.95]

FDA issues an alert on a Kadesh recall of all lots of Puriton Eye Relief Drops due to non-sterile production conditions at the man...

SpringWorks Therapeutics Gets Fast Trak for Nirogacestat

[ Price : $8.95]

FDA grants SpringWorks Therapeutics a fast track designation for nirogacestat, a selective gamma-secretase inhibitor under develop...

FDA Approves New OTC Primatene Mist

[ Price : $8.95]

FDA approves a revised OTC version of Primatene Mist for a small group of asthma users.

FDA Posts MyStudies App Code

[ Price : $8.95]

FDA posts computer code for its MyStudies app so patients can input real-world data for clinical trials, registries, and other use...

Draft Guide on Drug Safety Meta-Analyses

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Federal Register notice: FDA makes available a draft guidance entitled Meta-Analyses of Randomized Controlled Clinical Trials to E...

Some Roche Handheld Medical Devices at Risk: Report

[ Price : $8.95]

The National Cybersecurity and Communications Integration Center says some Roche handheld medical devices are vulnerable to cyber ...

MRI Interventions ClearPoint Software Upgrade

[ Price : $8.95]

FDA clears an MRI Interventions 510(k) for its latest software platform, ClearPoint 2.0.

FDA Clears Brain Bleed Software Detector

[ Price : $8.95]

FDA clears a MaxQ AI 510(k) for its Accipio Ix intracranial hemorrhage detection software.

Info Collection on Postmarket Drug Reporting

[ Price : $8.95]

Federal Register notice: FDA submits to OMB a revised information collection on Postmarketing Adverse Drug and Biological Product ...