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Comments Extended on Diagnostics for Antimicrobial Resistance

[ Price : $8.95]

Federal Register Notice: FDA extends the comment period for its guidance on infectious disease next-generation sequencing based di...

FDA Corrects Regs on Device Bans

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Federal Register Final rule: FDA amends its regulations to correct an error in the lists of provisions providing an opportunity fo...

FDA Corrects Regs on NADA Hearing Procedures

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Federal Register Final rule: FDA makes technical, nonsubstantive corrections to its regulations for hearing procedures on denying ...

FDA Clears iPEP System for Measuring Inspiratory Capacity

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FDA clears a D R Burton Healthcare Products 510(k) for its iPEP system, an oscillating positive expiratory pressure product for me...

Novogen Submits IND for Cantrixil in Ovarian Cancer

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Australia-based Novogen files an IND for TRX-E-002-1 (cantrixil) for treating ovarian cancer.

FDA Approves Herons Sustol for Treating Nausea

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FDA approves a Heron Therapeutics for Sustol (granisetron) extended-release injection, a serotonin-3 (5-HT3) receptor antagonist i...

Sanuwave De Novo Petition for Diabetic Foot Ulcer Device

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Sanuwave Health files a de novo petition requesting CDRH review and classification of the dermaPACE System for treating diabetic f...

Apotex Loses Tizanidine Appeal Against Acorda

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An appeals court panel upholds decisions rejecting Apotex claims that Acorda violated anti-trust and false advertising laws with i...

FDA Gives Thumbs Up to Eisai Phase 3 Alzheimers Study

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FDA gives Eisai the green light to move its early Alzheimers disease drug E2609 into Phase 3 clinical studies after discussing dat...

Data Not Strong Enough to Stop Abemaciclib Breast Cancer Trial: Lilly

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Eli Lilly says that after a pre-planned interim analysis of its MONARCH 2 study involving abemaciclib, an independent Data Monitor...