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FDA Revokes Emergency Use OK for Zika Test

[ Price : $8.95]

Federal Register notice: FDA revokes an Emergency Use Authorization issued to InBios International for the ZIKV Detect 2.0 IgM Cap...

Annual Report on Closed Advisory Panel Meetings

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Federal Register notice: FDA releases an annual report on agency advisory committees that held closed meetings during fiscal year ...

FDA Warns on Paclitaxel-coated Devices Mortality Signal

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In an 8/7 letter to physicians, FDA says updates to device labeling and clinical trial informed consent documents are coming becau...

FDA Funding Rare Disease Data Platform Meeting

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FDA funds a meeting to launch a new rare disease data analytics platform.

NvisionVLE Imaging System OKd for Pancreas/Bile Duct

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FDA clears a NinePoint Medical for the NvisionVLE Imaging System for use in the pancreas and bile duct.

FDA Should Address Approval Rate Factors: GAO

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The Government Accountability Office suggests ways in which FDA could address factors that restrict generic drug first review cycl...

Blueprint NDA Gets Priority Review for Avapritinib

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FDA accepts for priority review a Blueprint Medicines NDA for avapritinib for treating adult patients with PDGFRA Exon 18 mutant g...

FDA Seeks Computational Heart Modeling Software

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FDA looks for potential vendors to perform whole heart simulations and studies.

Grassley Wants Unannounced Foreign Drug Inspections

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Sen. Grassley asks FDA to resume unannounced inspections at foreign drug manufacturing facilities.

Fabry Disease Drug Development Guidance

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FDA issues a draft guidance on developing drugs to treat Fabry Disease.