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Naropin Not Withdrawn Due to Safety/Efficacy

[ Price : $8.95]

Federal Register notice: FDA determines that Fresenius Kabi USAs Naropin (ropivacaine HCl) solution was not withdrawn due to safet...

Non-Invasive Monitoring Enforcement Guide

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FDA publishes an immediately effective guidance removing an expiration for some enforcement policies for certain non-invasive remo...

FDA Approves UCBs Psoriasis Therapy

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FDA approves a UCB BLA for Bimzelx (bimekizumab-bkzx) for treating moderate-to-severe plaque psoriasis in adults who are candidate...

FDA Clears Intellia IND for Phase 3 Trial

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FDA clears an Intellia Therapeutics IND to permit a Phase 3 trial of its NTLA-2001 to treat transthyretin amyloidosis with cardiom...

FDA Clears GE Pulse Imaging System

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FDA clears a GE HealthCare 510(k) for its Allia IGS Pulse imaging system.

Praxis 510(k) for Biopsy Device Cleared

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FDA clears a Praxis Medical 510(k) for its EndoCore EBUS-TBNA fine needle biopsy device.

Former FDA Lawyer Joins Faegre Drinker

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After 15 years at FDA, former senior regulatory counsel Joy Sharp joins the law firm Faegre Drinker as counsel in Washington, DC.

Keytruda OKd Before/After Lung Cancer Surgery

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FDA approves Mercks Keytruda (pembrolizumab) for use with platinum-containing chemotherapy as neoadjuvant treatment and continuing...

Testing Pharma Alcohols for Methanol Guide

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Federal Register notice: FDA makes available a final guidance entitled Policy for Testing of Alcohol (Ethanol) and Isopropyl Alcoh...

Guide on Diabetic Foot Infection Drugs

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Federal Register notice: FDA makes available a draft guidance entitled Diabetic Foot Infections: Developing Drugs for Treatment.