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Nitrosamine Acceptable Intake Limits Guide

[ Price : $8.95]

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

Mesoblast Sent Another Complete Response Letter

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FDA sends Mesoblast a second complete response letter on its BLA for remestemcel-L for treating pediatric steroid-refractory acute...

Biosense Webster New Label on Cardiac Ablators

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FDA approves new labeling to permit several Biosense Webster cardiac ablation devices to be used without relying on a fluoroscopy ...

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Federal Register notice: FDA posts a draft guidance entitled PDUFA Waivers, Reductions, and Refunds for Fixed-Combinations and Sin...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Federal Register notice: FDA makes available a draft guidance entitled Fixed-Combinations and Single-Entity Versions of Previously...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...

WLF Claims Win In Lexapro Case Dismissal

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Washington Legal Foundation says the 2nd Circuit Court of Appeals upheld the dismissal of a case against Forest Pharmaceuticals ov...

CDER into Bispecific Antibody Research, Application

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An FDA online paper describes CDER research into and clinical applications of bispecific antibodies.