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Bill Seeks to Shift Drug Making to U.S.

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Congresswoman Claudia Tenney (R-NY) introduces the Producing Incentives for Long-term Production of Lifesaving Supply of Medicines...

Covid Container Closure Guidance Still Effective

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FDA says a Covid-19 guidance on container closure systems is expected to be effective until 8/7/2024.

J&J Plans 2024 Surgery Robot IDE Trials

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Johnson & Johnson says it will submit an IDE in the second half of 2024 to start trials of its Ottava surgical robot.

One-Third of BTD Requests Granted: Analysis

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CDER researchers say 39% of breakthrough therapy designation requests between 2017 and 2019 were approved by FDA.

Koru Medical Prefilled Syringe Pump Cleared

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FDA clears a Koru Medical Systems 510(k) for the Freedom60 Infusion System with Hizentra 50 mL prefilled syringes.

Orphan Status for Breast Cancer Radiotherapy

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FDA grants Plus Therapeutics an orphan drug designation for rhenium obisbemeda, an injectable radiotherapy for treating breast can...

Guide on Item Response Theory Clinical Data

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FDA releases a final guidance entitled Submitting Clinical Trial Datasets and Documentation for Clinical Outcome Assessments Using...

Guide on Device Export Certifications

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FDA reissues a guidance document entitled Process to Request a Review of FDAs Decision Not to Issue Certain Export Certificates fo...

Neurovalens Insomnia Neurostimulation Cleared

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FDA clears a Neurovalens 510(k) for its Modius Sleep neurostimulation device for treating chronic insomnia.

Foradil Not Withdrawn Due to Safety/Efficacy

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Federal Register notice: FDA determines that Novartis Foradil (formoterol fumarate) inhalation powder (.012 mg) was not withdrawn ...