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Regulatory Focus Articles RSS Feed 2.0
23 May 2022
The US Food and Drug Administration published two draft guidances and a revised final guidance that relax its regulatory oversight of blood and blood component donations. The agency says the changes make it easier for donation centers to receive b...

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23 May 2022
The European Commission’s Medical Device Coordination Group (MDCG) on 20 May issued a   question and answer guidance to help the medical device industry comply with unique device identification (UDI) requirements under the Medical Device Regulati...
23 May 2022
Drugs with blockbuster status and those approved under the US Food and Drug Administration’s (FDA’s) accelerated approval pathway were more likely to receive a new formulation, while other factors like clinical effectiveness were not predictive of...
20 May 2022
Welcome to another installment of This Week at FDA, your weekly source for updates – big and small – on FDA, drug and medical device regulation and what we’re reading from around the web. It was a busy week for FDA on the Hill again, with FDA Comm...

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01 April 2022