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FDA Alert on Compounded Semaglutide

[ Price : $8.95]

FDA alerts patients and healthcare providers to concerns about compounded semaglutide that is being produced as an alternative to ...

CDER Risk, Safety Report for 2022 Issued

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The CDER Office of Surveillance and Epidemiology 2022 annual report highlights activities in public health emergencies, drug risk ...

FDA Limited in Managing Drug Shortages: Pazdur

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Oncology Center of Excellence director Richard Pazdur explains what FDA can and cant do to address cancer drug shortages.

FDA Inactivating Cell/Tissue Product Registrations

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Federal Register notice: FDA intends to inactivate the registration of establishments that manufacture human cells, tissues, or ce...

FDA Proposes 1-Page Patient Medication Information

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FDA proposes a regulation to replace the current Medication Guides with a one-page Patient Medication Information sheet.

Violations at Advanced Compounding Solutions

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FDA warns Woburn, MA-based Advanced Compounding Solutions about multiple violations in its production of unapproved and misbranded...

Priority Review for BMS Lung Cancer Drug

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FDA accepts for priority review a Bristol Myers Squibb NDA for repotrectinib and its use for treating patients with ROS1-positive ...

Blue Earth PET Imaging Drug Approved

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FDA approves Blue Earth Diagnostics Posluma (flotufolastat F 18) injection, a prostate-specific membrane antigen-targeted positron...

Concerns with Macular Degeneration Guidance

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A developer of drugs to treat neovascular age-related macular degeneration raises issues with an FDA draft guidance on developing ...

Iovance Bio Gets Priority Review for Melanoma BLA

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FDA accepts for priority review an Iovance Biotherapeutics BLA submission for lifileucel, a tumor infiltrating lymphocyte therapy ...