Perspectives

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NICE Technical Engagement Process: Navigating the Latest Changes
Over the course of our multiple recent conversations with the UK’s National Institute for Health and Care Excellence (NICE) as part of decision problem and checkpoint meetings, we are hearing from them that they are currently trialing revisions to their technical engagement process in an effort to address some of the challenges that have begun to emerge since its initial release.
Whitepaper Aug 21, 2020
Medical Affairs Unscripted | The Business Objective of Medical Affairs with Holly Schachner, MD
During this episode of Medical Affairs Unscripted, Dr Crowley-Nowick has a conversation with Holly Schachner, MD, former CMO of Specialty Medicine at Allergan to examine the business objective of medical affairs (MA) organizations and how MA can move closer to being identified as a strategic pillar within the life sciences industry alongside the research & development and commercial organizations.
Podcast Jul 20, 2020
Evolving FDA Thinking on Advisory Committee Meetings Related to Foods, Drugs, and Devices
FDA advisory committee meetings are important regulatory events for many manufacturers on the path to marketing approval. These meetings can quite literally result in the approval or rejection of a product based on the panel’s vote. Not surprisingly, investors highly scrutinize these proceedings and stock markets react accordingly. For these reasons, it is critical for companies to have a clear understanding of FDA’s thinking related to these meetings.
View Jun 25, 2020