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Comments Sought on 8 Drugs for WHO Scheduling

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Federal Register notice: FDA seeks comments concerning abuse potential and the impact of scheduling changes on availability for me...

Guide on Nitrosamine Acceptable Intake Limits

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Federal Register notice: FDA makes available a final guidance entitled Recommended Acceptable Intake Limits for Nitrosamine Drug S...

Drger Recalls Carina Ventilators

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Drgerwerk recalls its Drger Carina Sub-Acute Care Ventilators due to the potential for contamination of the breathing gas.

Orphan Status for BRAF Inhibitor

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FDA grants ABM Therapeutics an orphan drug designation for ABM-1310, a novel small molecule BRAF inhibitor for treating patients w...

Guide on Drug Supply Chain Security

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Federal Register notice: FDA makes available a final guidance entitled Waivers, Exceptions, and Exemptions from the Requirements o...

K-TAB Not Withdrawn Due to Safety/Efficacy

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Federal Register notice: FDA determines that KTAB (potassium chloride) extended-release tablets were not withdrawn due to safety o...

Figueroa Permanently Debarred by FDA

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Federal Register notice: FDA permanently debars Raidel Figueroa from providing services in any capacity to a person that has an ap...

Regeneron Prostate Cancer Trial Stops Enrollment

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Regeneron says it has discontinued enrollment in a Phase 1 prostate cancer study of REGN5678, which is studying the combination us...

FDA Floats AI Modeling to Help Assess Drug Safety

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FDA discusses a new drug safety initiative that aims to develop artificial intelligence models for toxicological endpoints that ar...

Nitrosamine Acceptable Intake Limits Guide

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FDA releases a final guidance entitled Recommended Acceptable Intake Limits for Nitrosamine Drug Substance-Related Impurities (NDS...