ARW ON RNA
FDA's Platform Guidance Raises Long-Term Questions For mRNA Makers
As I read through the FDA's draft platform designation guidance and listened to various panel discussions the past few months, a handful of additional observations and considerations came to mind that are important to reiterate for the RNA space, particularly as we advance into therapeutics development.
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![small business search-GettyImages-149282415]( "FDA's Platform Guidance Raises Long-Term Questions For mRNA Makers")
FDA's Platform Guidance Raises Long-Term Questions For mRNA MakersAs I read through the FDA's draft platform designation guidance and listened to various panel discussions the past few months, a handful of additional observations and considerations came to mind that are important to reiterate for the RNA space, particularly as we advance into therapeutics development.
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MEET ARW
I’ve spent the past 10 years building relationships across the biologics and advanced therapies industry. In addition to hosting conversations and writing thought leadership articles, my goal as the editorial and community director for Advancing RNA is to find creative ways for the RNA (and broader ATMP) space to discuss, debate, and ultimately define a mature RNA therapeutics industry.
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FREE EBOOK: MODERNA'S REGULATORY JOURNEY
This collection of articles tells the story of how Moderna brought one of the first mRNA vaccines to the market and has all the makings of a legend we will pass down through generations. However, unlike the legends of King Arthur or The Fountain of Youth, we can celebrate that Moderna’s legendary journey was — and still is — real.
VIRTUAL EVENTS
- Can We Do Better? Current & Future Realities of mRNA Process Development
- Opening The “Black Box” Of The mRNA Regulatory Paradigm
- Got Raw Materials? The State Of The mRNA Supply Chain
- mRNA For Cancer Immunotherapy: 2024 Outlook
- mRNA Update: Beyond Prophylactic Vaccines
- Risk Reduction In mRNA Therapeutic Development
NEWSLETTER ARCHIVE
- 09.12.24 -- Let's Deviate From Deviations - Sterile Drugs.
- 09.11.24 -- Is This The Hardest Question Facing mRNA Therapeutics Makers?
- 09.04.24 -- Why Bridge RNA Is Taking The RNA Space By Storm
- 08.28.24 -- The RNA Challenge Keeping RNA Execs Up At Night
- 08.26.24 -- Solutions For mRNA And Nanoparticle Manufacturing
- 08.21.24 -- Innovation Advances In mRNA Medicine