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House Passes FDA Spending Bill with $41 Million Boost

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The U.S. House of Representatives passes an FDA spending bill that sets the agencys 2021 discretionary funding at $3.212 billion, ...

Guided Therapeutics Study Protocol for Cervical Scan

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Guided Therapeutics says it has submitted a clinical study protocol to FDA to support marketing of its LuViva Advanced Cervical Sc...

Vaccines Remarkably Safe Over Last 20 Years

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Israeli researchers say FDA has a robust vaccine approval and postmarketing surveillance system that worked well over the 20 years...

Woodcock and Colleagues Defend Integrated Reviews

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CDER director Janet Woodcock defends the Centers use of integrated reviews from criticisms that they wont meet agency goals and ma...

Hikma Phenylbutazone ANADA Withdrawn

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Federal Register notice: FDA withdraws approval of Hikma International Pharmaceuticals no-longer-marketed abbreviated new animal d...

Draft Guide on Setting Endotoxin Limits for Cancer Therapies

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FDA posts a draft guidance entitled Setting Endotoxin Limits During Development of Investigational Oncology Drugs and Biological P...

Multiple Function Device Guidance

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FDA issues a guidance on its regulatory approach and policy for multiple function device products.

CGMP, Other Violations Seen in Eosera Inspection

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FDA warns Eosera about CGMP and unapproved new drug violations in its production of OTC otic medications.

CGMP, Unapproved New Drug Violations at Tender

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FDA warns Tender about CGMP and unapproved and misbranded new drug violations in its production of several over-the-counter drug p...

American Medical Aesthetics Stem Cell Products

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CBER says American Medical Aesthetics and Regenerative Medicine is marketing stem cell products without a valid BLA in place.