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Regulatory Focus Articles RSS Feed 2.0
17 September 2021
An advisory committee to the US Food and Drug Administration (FDA) voted 16-2 on Friday against approval of a third booster dose added on to the 2-dose regimen for Pfizer’s COVID-19 vaccine Comirnaty. However, the committee voted unanimously in fa...

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16 September 2021
One Office of Data Transformation focus will be to reduce redundancy within FDA by integrating and streamlining data and IT processes when feasible by such means as encouraging the use of shared services and a more consistent approach to data mana...
16 September 2021
Some manufacturers are failing to grasp the step change in clinical and risk management requirements imposed by the Medical Devices Regulation (MDR), Kevin Butcher told attendees at RAPS Convergence 2021.  
16 September 2021
MedTech Europe has estimated as few as one-quarter of currently available in vitro diagnostics (IVDs) will be certified under the incoming regulations by the time they take effect next year. The trade group based its forecast on a survey of IVD ma...