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Ex-FDA Investigator Grumet Joins Greenleaf Health

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Regulatory consulting firm Greenleaf Health adds former FDA field investigator Kristen Grumet as senior vice president for regulat...

FDA Clarifies Field Action Reports Guidance

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Attorney Jennifer Davidson outlines clarifications included in a draft FDA guidance on submission of field alert reports.

Final Orphan Pediatric Drug Designation Guidance

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FDA announces availability of a finalized guidance on orphan drug designation for pediatric subpopulations of common diseases.

Guide on Peripheral Vascular Atherectomy Devices

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FDA releases a draft guidance entitled Peripheral Vascular Atherectomy Devices Premarket Notification [510(k)] Submissions.

ADMA Bio Gets FDA Close Out on Recent Inspection

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FDA tells ADMA Biologics that it has closed out an April Establishment Inspection Report issued after a compliance inspection at t...

AngioDynamics Resolves False Claims Cases

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AngioDynamics agrees to pay $12.5 million to resolve False Claims Act allegations relating to two medical devices.

Panel Votes Down GSKs Mepolizumab in COPD

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FDAs Pulmonary Allergy Drugs Advisory Committee votes 16 to 3 against approving the use of GSKs mepolizumab as an add-on treatment...

Info Collection Extension for Product Interruption Notices

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Federal Register notice: FDA submits to OMB an information collection extension for Permanent Discontinuation or Interruption in M...

Rare Disease Effectiveness Guidance

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FDA issues a draft guidance to help sponsors understand the evidence necessary to demonstrate effectiveness of drugs used for slow...

FDA Hearing on Improving Biosimilar Marketplace

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Federal Register notice: FDA announces a 9/4 public hearing on its approach to enhancing competition and innovation in the biologi...