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Panel Reviewing Ipsen NDA Postponed

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FDA says it is postponing a 10/31 Endocrinologic and Metabolic Drugs Advisory Committee meeting that was scheduled to review and v...

CGMP, Other Violations at Advanced Cosmetic Lab

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FDA warns Chatsworth, CA-based Advanced Cosmetic Research Laboratories about CGMP violations and marketing of misbranded unapprove...

Jubilant Generics FDA-483

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FDA releases the form FDA-483 with six observations from an inspection at Indias Jubilant Generics.

NeuroOne Medical Brain Electrodes Get Clearance

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FDA clears a NeuroOne Medical Technologies 510(k) to market its Evo sEEG Electrode technology for temporary (less than 30 days) us...

Imjudo/Imfinzi Approved for Liver Cancer

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FDA approves AstraZenecas Imjudo (tremelimumab) in combination with Imfinzi (durvalumab) for treating adult patients with unresect...

Guidances on ANDA Bioequivalence for Topicals

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Federal Register notice: FDA makes available additional draft and revised draft product-specific guidances for developing topical ...

FDA Nixes Cefazolin as Surrogate Agent for Cephalosporins

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FDA determines there are insufficient data to support a proposed cefazolin susceptible minimum inhibitory concentration breakpoint...

Warning Letter Close Out for Innova Medical

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FDA closes out a Warning Letter issued to Innova Medical Group over its unauthorized Covid-19 test following a recent inspection t...

Gene Therapy Neurodegenerative Disease Guide

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Federal Register notice: FDA makes available a final guidance entitled Human Gene Therapy for Neurodegenerative Diseases; Guidance...

Gormley Adds Oncology Endpoint Role at FDA

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CDER Division of Hematologic Malignancies 2 division director Nicole Gormley is named acting associate director for oncology endpo...