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ICH M14 Pharmacoepidemiological Studies Guide

[ Price : $8.95]

FDA publishes a draft International Conference on Harmonization M14 guidance on planning, designing, and analyzing observational p...

Device Total Product Life Cycle Advisory Program Continues

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CDRH extends its Total Product Life Cycle Advisory Program to include devices reviewed in the Office of Radiological Health, the D...

Guidance on Addressing Regulated Product Misinformation

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FDA publishes a draft question-and-answer guidance to help firms address misinformation about their approved or cleared medical pr...

Guide on Combo Product Risk Analyses

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FDA posts a draft guidance entitled Purpose and Content of Use-Related Risk Analyses for Drugs, Biological Products, and Combinati...

FDA WEBVIEW CLOSED JULY 4TH WEEK

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In annual observance of the Fourth of July (Independence Day) holiday in the U.S., FDA Webview closes its news operations until Mo...

Brookfield Medical/Surgical FDA-483

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FDA releases the form FDA-483 with four observations from an inspection at the Brookfield, CT-based Brookfield Medical/Surgical Su...

Complete Response on Rocket Gene Therapy

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FDA issues Rocket Pharmaceuticals a complete response letter on its BLA for gene therapy Kresladi (marnetegragene autotemcel; marn...

Shorla Oncology Breast/Ovarian Cancer Drug OKd

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FDA approves a Shorla Oncology NDA for Tepylute (thiotepa), a ready-to-dilute formulation for treating breast and ovarian cancer.

Promising Myasthenia Gravis Trial Data: J&J

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Johnson & Johnson reports positive data from its Phase 3 Vivacity-MG3 study of nipocalimab in patients with generalized myasthenia...

Praise for Biological Labeling Draft Guidance

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The Biosimilars Council and Biosimilars Forum praise a revised FDA draft guidance on biosimilar promotional labeling.