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Michael McCaughan on Muck Rack

Michael McCaughan

As seen in: Scrip, The Pink Sheet, The Irish Times, Generics Bulletin, HBW Insight, Citeline, Medtech Insight, Friends of Cancer Research, Source Magazine, The Pink Sheet Podcast, Win the Inbox Podcast
Founding Member, Prevision Policy LLC Business Implications of FDA and CMS Policy; Policy Implications of Biopharma Business
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Articles

What Is The Purpose Of Drug Repurposing?

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By Michael McCaughan
| The Pink Sheet Verified
Former acting Commissioner Woodcock urges FDA not to focus on updating product labels as part of its repurposing initiative, and instead focus on steps that can change medical practice. That message may be resonating with the agency. They didn't change the owner's manual, but this is still useful.
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Replimune Did Not Frame Adcomm Meeting As US FDA Failure, Which May Have Helped Gain Support

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By Michael McCaughan
| The Pink Sheet Verified
Replimune’s successful advisory committee outcome for RP1 is primarily a testament to the broad support from the melanoma community, but using a prior agency review to support its cause may have helped change some minds. RP1 is undergoing its third FDA review. (Shutterstock) Key Takeaways Replimune’s positive advisory committee recommendation for RP1 could have been influenced by FDA staffing changes, along with advocate support.
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Compounding The Problem: Peptides And The US FDA Advisory Committee Process

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By Michael McCaughan
| The Pink Sheet Verified
The FDA should hope the July FDA advisory committee review of peptide ingredients for compounding does not set a precedent for committee operations going forward. The recent PCAC meeting could set a concerning precedent for the FDA advisory committee process. (Shutterstock) Key Takeaways The FDA’s advisory committee meeting on peptide compounding was unique and a potentially dangerous precedent.
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