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User Fee Report on Drug/Biosimilar Review Resources

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Federal Register notice: FDA posts a user fee-related report providing options and recommendations for a new methodology to assess...

Panel Review of GSK Trelegy Ellipta sNDA Postponed

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Federal Register notice: FDA postpones a 4/21-planned Pulmonary-Allergy Drugs Advisory Committee meeting that was scheduled to dis...

CGMP Violations at Global Treat

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FDA warns Romanias Global Treat Srl about CGMP violations in its production of finished drugs.

Stakeholders Comment on Biosimilars Labeling Guidance

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Three stakeholders tell what they like about an FDA draft guidance on biosimilar promotional advertising and labeling.

FDA Backing Off Some Ophthalmic Device Enforcement

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FDA says it will exercise enforcement discretion for some ophthalmic assessment and monitoring devices during the coronavirus pand...

Supply Chain Issues Seen in Covid-19 Fight

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A Society of Corporate Compliance and Ethics white paper recommends ways to build a resilient healthcare supply chain once the cor...

QS Violations at Mandelay Kft

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FDA warns Hungarys Mandelay Kft about Quality System violations in its manufacturing of two medical devices.

Boston Scientific Recalls Imager Angiographic Catheters

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Boston Scientific recalls its Imager II 5F Angiographic Catheters because there is a potential for the catheter tip to become deta...

Views on Biosimilar Competitive Marketplace

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Two stakeholders comment on an FDA/FTC public workshop on a biosimilars competitive marketplace.

FDA Clears Nitiloop NovaCross Microcatheter

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FDA clears a Nitiloop 510(k) for its NovaCross CTO Microcatheter and its use in intraluminal placement of conventional and steerab...