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GE Recalls Neo-Natal Incubators

[ Price : $8.95]

GE Healthcare recalls its Giraffe OmniBed neo-natal incubator after receiving reports about the screw that secures the door becomi...

BioNTech Partial Hold on Lung Cancer Trial

[ Price : $8.95]

FDA issues a partial clinical hold on a BioNTech and OncoC4, Phase 3 trial that is assessing gotistobart in non-small cell lung ca...

Neurodevelopmental Safety Studies in Neonatal Products

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FDA publishes a guidance outlining a framework for considering the types of long-term neurodevelopmental safety studies that could...

FDA Continues to Review Ocaliva sNDA

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FDA says it is continuing to review the sNDA submitted by Intercept Pharmaceuticals for its Ocaliva following an advisory committe...

AbbVie NDA for Parkinsons Drug Approved

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FDA approves an AbbVie NDA for Vyalev (foscarbidopa and foslevodopa), a subcutaneous 24-hour infusion of levodopa-based therapy fo...

Guide on Postoperative Nausea/Vomiting Drugs

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FDA posts a draft guidance entitled Postoperative Nausea and Vomiting: Developing Drugs for Prevention.

Comments Extended on Conformance Assessment Program

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Federal Register notice: FDA extends the comment period on a 9/23 notice about three draft guidance documents related to CDRHs Acc...

FDA Wants Integrated Drug Review Feedback

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Attorney Deborah Livornese says FDA wants user feedback on the NDA integrated review format it has been publishing for several yea...

Cancer Trial Core Patient-Reported Outcomes Guide

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FDA publishes a guidance with recommendations for collecting a core set of patient-reported clinical outcomes in cancer clinical t...

Guide on ANDA Reconsideration Requests

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Federal Register notice: FDA makes available a final guidance requesting the reconsideration of an ANDA decision at the division l...