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Federal Register notice: FDA makes available a draft guidance entitled Meta-Analyses of Randomized Controlled Clinical Trials to E...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

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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

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

Karyopharm Fast Track for B-cell Lymphoma Drug

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FDA grants Karyopharm Therapeutics a fast track designation for selinexor, the companys first-in-class, oral Sine compound for tre...

Suggestions to Change Cancer Placebo Guidance

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Five major drug companies suggest changes to an FDA draft guidance on using placebo controls in cancer clinical trials.

7 Observations in MedisourceRx FDA-483

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FDA releases the FDA-483 with seven observations following an inspection at MedisourceRx.

Guide on Developing Fixed-Combination Hypertension Drugs

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Federal Register notice: FDA makes available a final guidance entitled Hypertension: Developing Fixed- Combination Drug Products f...