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Doctors, Health Systems Should Test Generics: Article

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A Health Affairs article calls on doctors and health systems to take steps to test generic drugs to minimize risks to patients.

Law Settles Active Ingredient Debate

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A Congressional Research Service report says a 2021 law codified FDAs approach to defining a new chemical entity in regulations in...

5 Pharmas Settle Improper Reimbursement Case

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Five drug companies agree to pay $42 million to settle a Texas enforcement action involving allegedly improper reimbursements for ...

HuidaGene Gets Rare Pediatric Drug Status

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FDA grants HuidaGene Therapeutics a rare pediatric disease designation for HG004 and its use in treating inherited retinal disease...

FDA Grants Traditional Approval to Gavreto

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FDA grants traditional approval for Genentechs Gavreto (pralsetinib) for treating adult patients with metastatic RET (rearranged d...

Galera Gets Complete Response on Mucositis Drug

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FDA sends Galera Therapeutics a complete response letter on an NDA for avasopasem manganese for radiotherapy-induced severe oral m...

Curiteva Navigation Instruments for Fusion Cleared

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FDA clears a Curiteva 510(k) for the Navigation Instrument System for use with its Prodigy Pedicle Screw System and SI-Lution Sacr...

Less Rigorous Standards in Drug Approvals: Study

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University researchers say a trend toward FDA approving new drugs based on less rigorous standards is continuing.

Biosimilars Workshop on Comparative Efficacy

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FDA and the International Pharmaceutical Regulators Programs Biosimilars Working Group announce a 9/12-13 virtual workshop on incr...

FDA Modernizing GCP Guidelines: Attorneys

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Morgan Lewis attorneys say a recent FDA draft guidance further demonstrates the agencys interest in modernizing good clinical prac...