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FDA Withdrawing 18 No-Longer-Marketed NDAs

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Federal Register notice: FDA withdraws approval of 18 NDAs from multiple applicants because the drug products are no longer market...

Moderna Delaying Pediatric Covid Vaccine EUA Filing

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Moderna says ongoing FDA safety concerns with Modernas Covid-19 vaccine and its potential use in adolescents has led to a filing d...

Draft Guide on Drug Reporting to FDA

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Federal Register notice: FDA posts a draft guidance entitled Reporting Amount of Listed Drugs and Biological Products Under Sectio...

Drug Name Study on Consumer/Doc Interpretations

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Federal Register notice: FDA seeks public comments on a proposed information collection entitled Text Analysis of Proprietary Drug...

Heart-assist Devices Recalled Due to Battery Risk

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Datascope/Getinge/Maquet recalls its Cardiosave Hybrid/Rescue Intra-Aortic Balloon Pump battery packs due to a battery failure ris...

Ex-Sales Rep Sentenced to 4 Years Over Fraud

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An Illinois federal judge sentences a former Aegerion Pharmaceuticals sales rep to 54 months in prison for using the identities of...

J&J Settles Risperdal Liability Cases for $800 Million

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Johnson & Johnson takes a $800 million hit to settle substantially all outstanding cases against its Risperdal drug product over p...

New Clozapine REMS Requires Recertification by 11/15

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FDA says that beginning 11/15 new requirements under the FDA-approved Clozapine Risk Evaluation and Mitigation Strategy (REMS) Pro...

Pfizer Covid Vaccine Authorized in Kids Aged 5-11

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FDA authorizes the emergency use of Pfizer-BioNTechs Covid-19 vaccine in children ages five through 11 years.

FDA May Get $300 Million Boost Under Infrastructure Bill

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A revised House reconciliation bill seeks to give FDA an additional $300 million for improving infrastructure.