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EMA confirms recommendation for non-renewal of authorisation of Duchenne muscular dystrophy medicine Translarna

Following re-examination, EMA’s human medicines committee (CHMP) has confirmed its initial recommendation to not renew the conditional marketing authorisation for Translarna (ataluren). This medicine is used for treating patients with Duchenne muscular dystrophy whose disease is caused by a type of genetic defect called a ‘nonsense mutation’ in the dystrophin gene and who are able to walk. The initial recommendation …

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FDA Publishes FY23 GDUFA Science and Research Report

Today, FDA’s Center for Drug Evaluation and Research published its fiscal year 2023 (FY23) Generic Drug User Fee Amendments (GDUFA) Science and Research Report. GDUFA-funded research aims to improve the efficiency with which generic drugs can be developed and assessed, and benefits public health in two critical ways: 1) making it more feasible for manufacturers to …

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FDA Celebrates Clinical Trials Day

The FDA’s Center for Drug Evaluation and Research (CDER) recently established the CDER Center for Clinical Trials Innovation (C3TI) to enable and amplify innovative approaches to clinical trials that are designed to improve the efficiency of drug development. To coincide with Clinical Trials Day, C3TI has publicly launched the C3TI Compass