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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
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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
How to Apply for an FDA Coronavirus Emergency Use Authorization Letter
Applying for a COVID-19 Emergency Use Authorization (EUA) Letter from FDA is no small feat, even though FDA has tried to simplify the process. We’ve worked directly with FDA on behalf of our clients (as authorized US agents) in order to address deficiencies or revise submissions based on evolving requirements.
Whitepaper May 27, 2020