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Tobacco Scientific Panel Members Sought

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Federal Register notice: FDA seeks nominations for members to serve on the Tobacco Products Scientific Advisory Committee.

Proposals Sought for Drug Excipient Pilot

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Federal Register notice: CDER announces its Novel Excipient Review Pilot Program and seeks initial proposals by 12/7.

Azurity Pharma Recalls 1 Firvanq Lot

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Azurity Pharmaceuticals recalls one lot of Firvanq (vancomycin hydrochloride for oral solution) 50 mg/mL kit because some products...

More Research Needed on Multiple Myeloma PRO Data: CDER

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CDER researchers say that more research is needed to determine the most appropriate approaches for statistical and analytical meth...

MDSAP Nonconformity Grading System Guidelines

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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

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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.