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Sue Sutter on Muck Rack

Sue Sutter

Verified
Washington, D.C.
As seen in: The Pink Sheet, BioXconomy, Internal Medicine News, MDEdge, Generics Bulletin, HBW Insight, In Vivo, Citeline, Medtech Insight, Scrip, Clinical Leader and
Senior Editor, Citeline's Pink Sheet, covering US FDA drug and biologic regulation and approvals. Views are my own. @PharmaPinkSheet
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Articles

Pink Sheet Podcast: MFN Finds Mid-Size Companies And More Vaccine Policy Moves

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By Derrick Gingery Verified, Maaisha Osman Verified, Sue Sutter Verified, Nielsen Hobbs Verified
| The Pink Sheet Podcast
Pink Sheet reporter and editors discuss the upcoming Most Favored Nation pricing agreements for small and mid-size companies and the impact of new proposed vaccine policy changes.
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FDA Container Closure Guidance Brings Combination Product Device Rules Under One Roof

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By Sue Sutter Verified
| Medtech Insight Verified
A recent draft guidance lists guiding principles and specific considerations for drug product container closure systems, while a separate guidance explains how to analyze user interface differences for biosimilar and interchangeable products. Recent FDA guidance on container closure systems applies to autoinjectors, pre-filled syringes, and other combination products used in drug delivery.
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US FDA Guidance Trims Pre-BLA Meeting Time, Again Clarifies INTERACT Meeting Scope

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By Sue Sutter Verified
| The Pink Sheet Verified
Final FAQ guidance on cell and gene therapy development reduces the length and number of questions for pre-BLA meetings and keeps most of the draft’s INTERACT language, but adds that the meeting type is meant for novel products posing unique early-development challenges. The FDA trimmed the time and number of questions for pre-BLA meetings. (Shutterstock) Key Takeaways The FDA once again tried to clarify the scope of INTERACT meetings in a final FAQ guidance on cell and gene therapy development.
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