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FDA AI Inspections Prompts Industry Readiness Strategy Rethink

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Former FDA enforcement official suggests new strategies for industry to prepare for agency inspections that rely on artificial int...

Agency Defends Generic Drug Oversight

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FDA officials are seeking to bolster confidence in generic medicines, highlighting the agency's oversight of drug manufacturing, i...

FDA Seeks Industry Data for Kidney Biomarker Initiative

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FDA launches a new effort to aggregate clinical trial data on kidney safety biomarkers, seeking pharmaceutical industry participat...

Alert on GE HealthCare Infant Resuscitation Systems

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FDA issues an early alert warning healthcare providers about a potentially high-risk defect affecting certain infant resuscitation...

PhRMA Urges FDA to Clarify Digital Health Technology Standards

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PhRMA calls on FDA to provide clearer regulatory expectations for the use of digital health technologies in drug development, argu...

FDA Expands Pfizer Bleeding Drug Approval

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FDA approves an expanded indication for Pfizer's hemophilia treatment Hympavzi (marstacimab-hncq), allowing its use in additional ...

Stakeholders Press FDA to Pause Voucher Program Amid Transparency Concerns

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Stakeholders at FDA's public hearing on the Commissioners National Priority Voucher program urge the agency to temporarily suspend...

House Passes $7.1 Billion FDA Spending Bill

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The House passes FDAs appropriations bill for fiscal year 2027 that provides $7.1 billion for the agency.

FDA Rejects Xspray Pharma's Nilopki Application

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FDA issues Xspray Pharma a complete response letter for the company's NDA for Nilopki, an improved formulation of nilotinib design...

FDA Breakthrough Device Designations Top 1,280

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FDA says its breakthrough devices program has surpassed 1,280 designations since its launch, highlighting the growing use of the e...