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Jill Murphy is Editor of Pharmaceutical Technology.
March 22, 2023
The decision was based on results from the PROpel Phase III trial.
This approval makes the drug the first and only targeted medicine indicated to treat this population of children in Europe and the United States.
March 21, 2023
Additionally, the MSG discussed plans to mitigate shortages of antibiotics for the next autumn and winter season.
Adam C. Fisher, PhD, director of Science Staff and Immediate Office/Office of Pharmaceutical Quality at the Center for Drug Evaluation and Research/FDA, discusses point of care and patient manufacturing with Pharmaceutical Technology editor Jill Murphy.
March 06, 2023
Any patients who have received the identified lots or have any questions regarding the recall should contact their pharmacy or immediately contact a health provider in terms of medical advice.
The guidance is intended to build on the existing International Council for Harmonisation (ICH) quality guidance.