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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Support for FDA Biosimilar Comparative Studies Draft Guidance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Four drug industry stakeholders say they support an FDA draft guidance proposing to reduce reliance on comparative efficacy studie...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Advanced Medical Technology Association urges FDA to narrow and clarify a draft guidance on quality management system information,...

Objectionable Conditions in Prodrome Sciences BIMO Inspection

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FDA warns Temecula, CA-based Prodrome Sciences USA about violations in its conduct of a clinical trial without submitting an IND.

Guide on Endpoints for Multiple Myeloma Accelerated Approval

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FDA posts a draft guidance outlining how drug developers can use minimal residual disease and complete response as primary endpoin...