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Draft Guide on Blood Pressure Monitoring Sensors

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FDA issues a draft guidance detailing expectations for how makers of cuffless, non-invasive blood pressure monitoring devices shou...

6 Observations in Lupin Nagpur Inspection

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FDA releases the form FDA-483 with six observations from an inspection at the Lupin sterile manufacturing facility in Nagpur, Indi...

Cogent Bio Plans NDA for Bezuclastinib

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Cogent Biosciences says FDA has agreed to accept the companys planned NDA for cancer drug bezuclastinib under the agencys Real-Tim...

FDA Soliciting PreCheck Pilot Applications

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FDA says it will start accepting applications on 2/1 for its new PreCheck Pilot program intended to boost domestic drug manufactur...

Support for FDA Biosimilar Comparative Studies Draft Guidance

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Four drug industry stakeholders say they support an FDA draft guidance proposing to reduce reliance on comparative efficacy studie...

FDA Push to Move More Drugs to OTC Status

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FDA commissioner Marty Makary discusses upcoming actions to encourage more prescription-to-over-the-counter drug switches.

IntraBio Reports Positive Phase 3 Data on Levacetylleucine

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IntraBio reports positive results from a pivotal Phase 3 clinical trial showing that levacetylleucine significantly improved neuro...

FDA Touts ImportShield Results

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FDA says its new ImportShield program improved processing speed and volume capacity while reducing staff hours in its first four m...

AdvaMed Urges FDA to Narrow Guidance on Device QMS

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Advanced Medical Technology Association urges FDA to narrow and clarify a draft guidance on quality management system information,...

Moderna/Merck Report Positive Data on Melanoma Vaccine

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Moderna and Merck report updated five-year follow-up data that show their personalized mRNA cancer vaccine candidate, intismeran a...