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Janssens TB Drug Converted to Full Approval

[ Price : $8.95]

FDA converts Janssens Sirturo (bedaquiline) from accelerated to traditional approval following a determination that a confirmatory...

Small Entity Compliance Guide on LDT Phase-out

[ Price : $8.95]

FDA releases a guidance entitled Laboratory Developed Tests: Small Entity Compliance Guide.

Endotronix Pulmonary Artery Sensor Approved

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FDA approves an Endotronix PMA for its Cordella Pulmonary Artery Sensor System for treating New York Heart Failure Class III heart...

Committee Finds Troubling Foreign Inspection Issues

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The House Energy and Commerce Committee seeks additional inspection records from FDA after its analysis of the foreign drug inspec...

FDA Denies Petition Seeking Wakix Withdrawal

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FDA denies a 4/2023 petition that called on the agency to withdraw approval for Harmony Biosciences Wakix (pitolisant) and take ot...

Switching Studies for Interchangeable Biosimilars Guide

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Federal Register notice: FDA makes available a draft guidance entitled Considerations in Demonstrating Interchangeability With a R...

Guide on Adulteration when Inspection Refused

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Federal Register notice: FDA makes available a final guidance entitled Circumstances That Constitute Delaying, Denying, Limiting, ...

Guide on Human User Safety in Animal Drugs

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Federal Register notice: FDA makes available a final guidance entitled Human User Safety in New and Abbreviated New Animal Drug Ap...

Workshop on NDA/BLA Meeting Management Practices

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FDA announces a 7/22 public workshop on Best Practices for Meeting Management Under PDUFA VII.

Lillys Files Mounjara NDA for Sleep Apnea

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Eli Lilly says it has submitted an NDA for weight loss therapy Mounjaro (tirzepatide) for treating moderate-to-severe obstructive ...