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The US Food and Drug Administration’s (FDA) top biologics regulator said the use of a “playbook” or platform approach for developin...
The New Zealand Medicines and Medical Devices Safety Authority (Medsafe) has revised its upcoming fee changes in light of industry f...
Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
More than half of the novel drugs approved by the US Food and Drug Administration (FDA) in 2020 were supported by a single pivotal t...
The US Food and Drug Administration (FDA) is working on ways to facilitate greater use of real-world data (RWD) to help understand t...
18 May 2022
19 May 2022