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Stimulant Use Disorder Drug Development Meeting

[ Price : $8.95]

Federal Register notice: FDA announces a 3/10 public meeting entitled Patient-Focused Drug Development for Stimulant Use Disorder....

Phillips Respironics Recalls Triology EVO Ventilators

[ Price : $8.95]

Philips Respironics recalls its Trilogy EVO Ventilator and Trilogy EVO Universal Ventilator due to a software defect.

FDA, India Stop 500 Illicit Product Shipments

[ Price : $8.95]

FDA says a joint enforcement operation conducted with India stopped about 500 shipments of illicit and potentially dangerous unapp...

GDUFA 2019 Science and Research Report

[ Price : $8.95]

CDER publishes a FY 2019 report detailing accomplishments under the GDUFA Science and Research Program.

Changes Sought in Draft Combination Product Bridging Guidance

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Boehringer Ingelheim asks for better alignment of examples in an FDA bridging draft guidance.

Savings Not Likely in FDA Drug Import Proposal: Analysis

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Manatt Health senior advisor Ian Spatz questions the viability of an FDA proposal to permit states to import drugs from Canada.

Comments Extended on Combo Product Bridging Guide

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Federal Register notice: FDA extends until 4/20 the comment period for a 12/2019 draft guidance on Bridging for Drug-Device and Bi...

CDRH Workshop on Computational Modeling Practices

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CDRH announces a 4/13-15 public workshop entitled Towards Good Simulation Practices in Health Technologies that will discuss model...

FDA Docket Seeks Data/Info on Vaping Injuries

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FDA establishes a docket to obtain data and information on vaping-related lung injuries to help identify and evaluate additional s...

Sellas Nelipepimut-S Phase 3 Study in Breast Cancer

[ Price : $8.95]

Sellas Life Sciences Group says that after gaining FDA feedback, it has finalized the design and plan for a Phase 3 study of nelip...