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May 23, 2022
Raps
MDCG guidance aims to h…

The European Commission’s Medical Device Coordination Group (MDCG) on 20 May issued a to help the medical device i…

May 23, 2022
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Study: Blockbuster, acc…

Drugs with blockbuster status and those approved under the US Food and Drug Administration’s (FDA’s) accelerated a…

May 23, 2022
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FDA takes steps to rela…

The US Food and Drug Administration published two draft guidances and a revised final guidance that relax its regu…

May 20, 2022
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This Week at FDA: House…

Welcome to another installment of This Week at FDA, your weekly source for updates – big and small – on FDA, drug …

May 17, 2022
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Asia-Pacific Roundup: N…

The New Zealand Medicines and Medical Devices Safety Authority (Medsafe) has revised its upcoming fee changes in l…

May 17, 2022
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FDA, EMA officials disc…

The US Food and Drug Administration’s (FDA) top biologics regulator said the use of a  “playbook” or platform appr…

May 17, 2022
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Study: Novel drug appro…

More than half of the novel drugs approved by the US Food and Drug Administration (FDA) in 2020 were supported by …

May 16, 2022
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FDA works to advance re…

The US Food and Drug Administration (FDA) is working on ways to facilitate greater use of real-world data (RWD) to…

May 16, 2022
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IVDR: Commission adds r…

The European Commission last week updated its list of officially recognized harmonized standards for diagnostics i…

May 13, 2022
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This Week at FDA: House…

Welcome to another installment of This Week at FDA, your weekly source for updates – big and small – on FDA, drug …

May 12, 2022
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Euro Convergence: Atten…

Corrected 13 May 2022* AMSTERDAM – Regulatory professionals have a big ask for regulators and other health authori…

May 12, 2022
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500+ gather in Amsterda…

RAPS today wrapped up the final day of Euro Convergence 2022, which took place live and in-person in Amsterdam aft…

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