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Drug Shortage Announcements Can Lead to Protective Purchasing: USP

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A United States Pharmacopoeia study finds that protective purchasing following information on drug shortages can adversely affect ...

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...

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FDA issues a draft guidance detailing expectations for how makers of cuffless, non-invasive blood pressure monitoring devices shou...

Sato Pharmaceutical FDA-483 Out

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FDA releases the form FDA-483 with 10 observations from an inspection at Japans Sato Pharmaceutical over-the-counter drug manufact...

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Advanced Medical Technology Association urges FDA to narrow and clarify a draft guidance on quality management system information,...

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Support for FDA Biosimilar Comparative Studies Draft Guidance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Four drug industry stakeholders say they support an FDA draft guidance proposing to reduce reliance on comparative efficacy studie...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.