Sue Sutter on Muck Rack

Sue Sutter

Verified
Washington, D.C.
As seen in: The Pink Sheet, BioXconomy, Internal Medicine News, MDEdge, Citeline, Generics Bulletin, HBW Insight, In Vivo, 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

US FDA Moves To Eliminate ‘Adequate Provision’ For DTC Broadcast Ads

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By Sue Sutter Verified
| The Pink Sheet Verified
The proposed rule targeted for December would force drugmakers to include all important risk information in an ad, a change the agency predicted will cost industry more than $100m annually. The FDA plans to require all important safety information be included within the narrow confines of a broadcast ad. (Shutterstock) Key Takeaways The FDA plans to release a proposed rule in December that would eliminate the “adequate provision” option for providing safety information in DTC broadcast ads.
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US FDA To Clarify, Expand ‘Significant Discretion’ To Publish CRLs

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By Sue Sutter Verified
| The Pink Sheet Verified
A proposed rule planned for October would end the “longstanding presumption” that an unapproved application’s existence is confidential, enabling proactive disclosure of complete response letters, the agency’s unified agenda states. A proposed rule on CRLs will shine more light on FDA decision-making, the agency said. (Shutterstock) Key Takeaways The FDA plans to issue a proposed rule on proactive disclosure of CRLs for drugs and biologics in October.
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US FDA’s Lisa Yanoff Takes Temple’s Vacant CDER Deputy Director For Clinical Science Spot

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By Sue Sutter Verified
| The Pink Sheet Verified
Yanoff, deputy director of the Office of Cardiology, Hematology, Endocrinology and Nephrology and an 18-year agency veteran, will temporarily fill the post previously held by agency legend Robert Temple, as CDER continues rebuilding its leadership ranks. CDER is bolstering its senior leadership team. (Shutterstock) Key Takeaways OCHEN Deputy Director Lisa Yanoff is CDER’s new acting deputy director for clinical science.
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