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Keep FDA Logo Out of Materials: Agency

[ Price : $8.95]

FDA reminds industry and others about its policy on using the FDA name and logo in any materials without being specifically author...

FDA Quality Management White Paper

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FDA publishes a white paper on the assessment approach to be used as part of CDERs Quality Management Maturity program.

Opioid Crisis Worse Despite Progress: Califf

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FDA commissioner Robert Califf says much remains to be done to combat the changing opioid crisis in the U.S.

Real-World Evidence Regulatory Guidance

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FDA publishes a guidance on using real-world data and evidence to support drug and biological product regulatory decision-making.

FibroGen Duchenne Study Misses Endpoint

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FibroGen says its Phase 3 LELANTOS-2 trial of pamrevlumab for treating ambulatory patients with Duchenne muscular dystrophy did no...

Hamilton Medical Recalls Ventilators

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Hamilton Medical recalls its Hamilton-C1, C2, C3, and T1 ventilators after receiving reports about software issues that may cause ...

Animal Extralabel Drug Use Info Collection

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Federal Register notice: FDA seeks comments on an information collection extension entitled Extralabel Drug Use in Animals -- 21 C...

Info Collection on CVM Dispute Resolutions

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Federal Register notice: FDA seeks comments on an information collection extension entitled Dispute Resolution Procedures for Scie...

Drug Distribution Security Guidance

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FDA publishes a guidance to assist drug supply chain stakeholders to meet the requirements for enhanced drug distribution security...

Drug Tracing Stabilization Period

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FDA issues two compliance guidances to implement a one-year stabilization period giving trading partners additional time to meet D...