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GDUFA Research Supports Generic Drug Development

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The FDA FY 2021 GDUFA Science and Research Outcomes Report demonstrates how GDUFA research projects have contributed to the develo...

FDA, C-Path Exploring Lysosomal Diseases Group

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FDA says it is partnering with the Critical Path Institute to explore creating a Lysosomal Diseases Consortium as part of the Acce...

eCential Robotics Bone Surgical System Cleared

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FDA clears an eCential Robotics 510(k) for its 3D imaging, navigation and robotics guidance system for use in bone surgical proced...

Respironics Troubles Broaden as it Pays $24 Mil. Over False Claims

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As it negotiates a consent decree over its ventilators and other airway devices with the Department of Justice (DoJ), the company ...

FDA Authorizes Moderna, Pfizer-BioNTech Boosters

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FDA authorizes Modernas and Pfizer-BioNTechs updated (bivalent) Covid-19 vaccines for use as a single booster dose at least two mo...

FDA Loses California Stem Cell Treatment Case

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A California federal judge rejects FDA regulation of a stem cell clinic, saying it is engaged in the practice of medicine.

Novo Nordisk Pays $6.3 Million Over False Claims

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Novo Nordisk agrees to pay $6.3 million to resolve allegations that it violated the False Claims Act by selling its NovoFine needl...

FDA OKs Genzymes Xenpozyme for ASMD

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FDA approves Genzymes Xenpozyme to treat acid sphingomyelinase deficiency in children and adults.

Changes Sought in Drug Shortage Draft Guidance

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Two major drug trade associations ask for changes in an FDA draft guidance on risk management plans to mitigate drug shortages.

Baxter New Novum IQ Syringe Pump Cleared

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FDA clears a Baxter International 510(k) clearance of its new Novum IQ syringe infusion pump with Dose IQ Safety Software.