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Regulatory Focus Articles RSS Feed 2.0
26 October 2021
Though the vote tally would indicate robust endorsement from the committee, the day’s presentations and discussions unfolded a more nuanced picture, with lingering concerns about a signal for myocarditis and pericarditis in older adolescents and y...

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26 October 2021
The European Commission (EC) on 22 October released a list of the 10 “most promising treatments” for COVID-19 as part of its strategy to support the development of new therapies.  
26 October 2021
The US Food and Drug Administration's (FDA) Center for Devices and Radiological Health (CDRH) on Tuesday released its list of guidances it intends to issue or finalize in FY2022, with new guidances planned and some documents making repeat appearan...
26 October 2021
Australia's Therapeutic Goods Administration (TGA) is seeking feedback on plans to make it mandatory for healthcare facilities to report adverse events linked to medical devices. Currently, only manufacturers and sponsors need to report adverse ev...