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K-TAB Not Withdrawn Due to Safety/Efficacy

[ Price : $8.95]

Federal Register notice: FDA determines that KTAB (potassium chloride) extended-release tablets were not withdrawn due to safety o...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

Meeting on Study Disruptions During Emergencies

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Federal Register notice: FDA announces a 10/18-19 public meeting entitled Mitigating Clinical Study Disruptions During Disasters a...

Guide on User Fee Waivers for HIV Drugs

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Federal Register notice: FDA posts a draft guidance entitled PDUFA Waivers, Reductions, and Refunds for Fixed-Combinations and Sin...

Guide on Antiretrovirals for HIV1 Under PEPFAR

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Federal Register notice: FDA makes available a draft guidance entitled Fixed-Combinations and Single-Entity Versions of Previously...

DSCSA Can Lead to Drug Shortages: Reps

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A bipartisan group of 28 House members asks FDA about the potential for drug shortages if supply chain members cant meet the 11/27...

DSCSA Waiver, Exception, Exemption Guidance

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FDA publishes a guidance explaining the process for requesting a waiver, exception, or exemption from provisions of the Drug Suppl...