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Drugs seeking Fast Track must only have the potential to address an unmet medical need, while drugs seeking Breakthrough Therapy designation must have preliminary data which demonstrate substantial improvement on clinically significant endpoints over available therapies. What is breakthrough device designation? FDA Breakthrough Device designation is granted to novel medicalRead More →

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It takes time for your body to build protection after any vaccination. People are considered fully vaccinated two weeks after their second shot of the Pfizer-BioNtech or Moderna COVID-19 vaccine, or two weeks after the single-dose J&J/Janssen COVID-19 vaccine. Why get vaccine if you’ve had Covid? Tafesse’s research has foundRead More →