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FDA Clears AdvaDx mecA XpressFISH Assay

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FDA clears an AdvanDx 510(k) for its new mecA XpressFISH assay for detecting methicillin-resistant and methicillin-susceptible Sta...

High-powered Lawyers Fighting LDT Proposal

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The American Clinical Laboratory Association says former solicitor general Paul Clements and Harvard law professor Lawrence Tribe ...

FDA Revises Guidance on 505(q) Citizen Petitions

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FDA posts a revised guidance on Citizen Petitions and Petitions for Stay of Action Subject to Section 505(q)of the Federal Food, D...

OIG Lists FDA Drug Safety Tasks

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The HHS Inspector General says there a number of tasks FDA needs to do to continue to ensure the safety of drugs and medical devic...

Frivolous Petitions Continue to be Submitted: FDA

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A new report from FDA to Congress says the agency is concerned that too many petitions continue to be submitted as a strategy to d...

Guidance on Rare Pediatric Disease Vouchers

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Federal Register Notice: FDA releases a draft guidance: Rare Pediatric Disease Priority Review Vouchers.

FDA Withdraws 14 NDAs

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Federal Register Notice: FDA withdraws approval of 14 NDAs from multiple application holders due to a failure to file annual repor...

FDA Corrects Notice on Withdrawn Drug Products

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Federal Register Proposed rule: FDA corrects the Regulatory Information Number in a 7/2 notice on additions and modifications to a...

FDA Clears K2M Capri Corpectomy Cage System

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FDA clears a K2M 510(k) for its Capri Corpectomy Cage System, an expandable vertebral body replacement device for use following a ...

FDA, CDC Award Contract for Vaccine Adverse Event System

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FDA and the Centers for Disease Control and Prevention award SRA International an $18 million contract to support the Vaccine Adve...