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Integrating RCTs into Routine Clinical Practice

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FDA publishes a guidance on integrating clinical trials into routine clinical practice.

Safety Alert on Zimmer Hip System

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FDA issues a safety alert about an increased risk of thigh bone fracture after surgery with the use of the Zimmer Biomet CPT Hip S...

SSM St. Clare Health Gets FDA-483

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FDA issues SSM St. Clare Health Center a 10-observation Form FDA-483 for GMP deficiencies found during an inspection at an outsour...

Guide on Oncology Multiregional Clinical Trials

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FDA posts a draft guidance entitled Considerations for Generating Clinical Evidence from Oncology Multiregional Clinical Developme...

3 De Novo Device Classifications

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Federal Register notices: FDA classifies three devices into Class 2 based on de novo classification requests Saladax Biomedicals ...

CVM Draft Guide on CMC Technical Section

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FDA releases a CVM draft guidance entitled Chemistry, Manufacturing, and Controls (CMC) Technical Section Filing Strategies.

Apple Watch Cleared for Assessing Sleep Apnea

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FDA clears an Apple 510(k) for its Apple Watch to be used as an over-the-counter device for assessing the risk of sleep apnea.

Boehringer Ingelheim Plans Pulmonatry Fibrosis NDA

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Boehringer Ingelheim plans an NDA for nerandomilast for treating idiopathic pulmonary fibrosis (IPF) after reporting that its Phas...

Fresenius Recalls Ivenix Pump Administration Sets

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Fresenius Kabi recalls (Class 1) one lot of the Ivenix Large Volume Pump primary administration sets after documenting a manufactu...

Clinical Hold Lifted on Zentalis Azenosertib

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FDA removes a partial clinical hold on Zentalis Pharmaceuticals azenosertib studies into the drugs use against solid tumors and tw...