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Real-World Evidence Regulatory Guidance

[ Price : $8.95]

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

[ Price : $8.95]

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

Hamilton Medical Recalls Ventilators

[ Price : $8.95]

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

[ Price : $8.95]

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

[ Price : $8.95]

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

Drug Distribution Security Guidance

[ Price : $8.95]

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

Drug Tracing Stabilization Period

[ Price : $8.95]

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

Comments on Increasing Home Medical Tech Use

[ Price : $8.95]

Five stakeholders respond to FDA docket questions about expanding home medical technology use.

FDA Renews 5-Year M-CERSI Agreement

[ Price : $8.95]

FDA approves a five-year $50 million contract renewal with the University of Maryland Center of Excellence in Regulatory Science a...

Aion Bio Temperature Monitor Cleared

[ Price : $8.95]

FDA clears an Aion Biosystems 510 (k) for its iTempShield device and software system for continuous measurement of body temperatur...