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MDSAP Nonconformity Grading System Guidelines

[ Price : $8.95]

FDAs Medical Device Single Audit Program issues a guideline on a five-level nonconformity grading system for medical devices.

CDER Director Keynote at Upcoming Sentinel Workshop

[ Price : $8.95]

The 13th Annual Sentinel Initiative Virtual Public Workshop 11/8-9 features a keynote address from CDER director Patrizia Cavazzon...

FDA Revises Covid ANDA Q&A Guidance

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FDA makes three revisions to a guidance containing questions and answers on developing ANDAs during the Covid-19 pandemic.

FDA to Reconsider Mandatory Opioid Prescriber Education

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FDA and the Duke-Margolis Center for Health Policy schedule a public meeting on the agencys plan to reconsider the need for mandat...

FDA Clears joimax Spinal Cages

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FDA clears a joimax 510(k) for the EndoLIF Delta Cage and EndoLIF DoubleWedge Cage, intended for intervertebral body fusion proced...

Genesis Ultra Gold is Unapproved Weight Loss Drug: FDA

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FDA warns Genesis Ultra Slim that its Ultra Slim Gold is a misbranded unapproved new weight loss drug.

FDA Approves Impel NeuroPharmas Trudhesa

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FDA approves Impel NeuroPharmas Trudhesa migraine nasal spray treatment.

TransMedics OCS Heart System Approved

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FDA approves a TransMedics Group PMA for its OCS Heart System for use with organs from donors after brain death.

Notice on Pediatric Panel Meeting Corrected

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Federal Register notice: FDA corrects an 8/10 notice announcing a 9/17 Pediatric Advisory Committee meeting.

Device Reclassification Petition Info Collection

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Federal Register notice: FDA seeks comments on an information collection extension entitled Reclassification Petitions for Medical...