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Target Health ANDA Withdrawals Notice Corrected

[ Price : $8.95]

Federal Register notice: FDA corrects a 3/29 notice on the approval withdrawals of 30 ANDAs from multiple applicants due to Target...

Human User Safety in Animal Drugs Guidance

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FDA publishes a guidance explaining how CVM assesses human user safety in applicable animal drug applications.

Synapse Labs Studies Unacceptable: FDA

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FDA tells NDA and ANDA sponsors they must repeat clinical and bioanalytical studies conducted for their applications by Synapse La...

Praise, Suggestions for RWE Studies Guidance

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Six stakeholders express appreciation for and suggest improvements to an FDA draft guidance on using real-world evidence in non-in...

2023 Trial Diversity Workshop Report

[ Price : $8.95]

FDA publishes its report on an 11/2023 workshop on increasing clinical trial diversity.

Guide on ANDA Facility Inspection Readiness

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Federal Register notice: FDA makes available a final guidance entitled Facility Readiness: Goal Date Decisions Under GDUFA.

Animal Drug User Fee Educational Conference

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Federal Register notice: FDA announces a 7/17 educational conference (public meeting) entitled First Annual Animal Drug User Fee E...

Former Device Company CEO Gets 6 Years in Prison

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A New York federal judge orders Stimwave founder and former CEO Laura Perryman to serve six years in jail for medical device healt...

FDA Asks Input on Non-Device Software Functions, Impacts

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FDA asks for input on certain non-device software functions and impacts on patient safety.

Protein Data Bank Aided 100% of Targeted Cancer Drugs: Study

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Academic researchers say all 34 low molecular weight, protein-targeted, antineoplastic agents approved by FDA between 2019 and 202...