Sue Sutter

Washington, D.C., United States

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

Merck’s Clesrovimab Vote Reflects New ACIP Members’ Skepticism

2 days ago | insights.citeline.com | Sue Sutter

Merck’s Clesrovimab Vote Reflects New ACIP Members’ Skepticism The new Advisory Committee on Immunization Practices members endorsed Merck & Co.’s monoclonal antibody for RSV prevention, but some questioned its use in healthy babies and potential interactions with vaccines given at the same time. Merck & Co's clesrovimab is recommended for prevention of RSV in infants. (Shutterstock)
New CDC Vaccine Panel Chair Vows To ‘Rebuild Public Trust’ With Evidence-Based Medicine

2 days ago | insights.citeline.com | Sue Sutter

New CDC Vaccine Panel Chair Vows To ‘Rebuild Public Trust’ With Evidence-Based Medicine The newly reconstituted Advisory Committee on Immunization Practices will create new work groups to examine the cumulative impact of vaccine schedules and reexamine some older vaccines. New members of the CDC's Advisory Committee on Immunization Practices met on June 25. (Screenshot of CDC Broadcast)
New CDER Deputy Director Michael Davis Brings Psychedelic Drug Development Experience

4 days ago | insights.citeline.com | Sue Sutter

New CDER Deputy Director Michael Davis Brings Psychedelic Drug Development Experience Davis, a former FDA team leader in the Division of Psychiatry Products, rejoins the agency from the Usona Institute, which develops psychedelics. His background aligns with Commissioner Martin Makary’s goal of seeing new treatments approved for post-traumatic stress disorder. CDER's new deputy director has a background in psychedelic drug development. (Shutterstock)
AI Will Bolster, Not Squelch, Patient Voice In Clinical Research, US FDA Says

1 week ago | insights.citeline.com | Sue Sutter

AI Will Bolster, Not Squelch, Patient Voice In Clinical Research, US FDA SaysArtificial intelligence tools used for clinical research should be developed with input from patients and focus on their needs and abilities, FDA experts said. Patients should be at the center of AI tool development for clinical research. (Shutterstock)
Post-Approval, Real-Time Monitoring Will Help Approval Standards, US FDA’s Makary Says

1 week ago | insights.citeline.com | Sue Sutter

Post-Approval, Real-Time Monitoring Will Help Approval Standards, US FDA’s Makary SaysThe FDA will use electronic health records to “get eyes” on drugs immediately after approval, Commissioner Martin Makary told the DIA 2025 Global Annual Meeting. He also wants to reduce development time with better communication and new approval pathways. FDA Commissioner Martin Makary and other international regulators, scientists and a patient spoke during the DIA Global Annual Meeting's opening plenary.
US FDA’s July AdComms: Pediatric Vaccine Safety, Blenrep’s Return, (Maybe) Capricor’s Cell Therapy

2 weeks ago | insights.citeline.com | Sue Sutter

US FDA’s July AdComms: Pediatric Vaccine Safety, Blenrep’s Return, (Maybe) Capricor’s Cell Therapy The Pediatric Advisory Committee will review postmarketing safety for three vaccines and the oncologic drugs panel will consider the return of GSK’s belantamab mafodotin. An FDA notice about a 30 July meeting on Capricor’s deramiocel for Duchenne muscular dystrophy was withdrawn. The FDA is adding advisory committee meetings to its July calendar. (Shutterstock)
US FDA Unveils Plans To Consolidate Support Services

2 weeks ago | insights.citeline.com | Derrick Gingery |Sue Sutter

US FDA Unveils Plans To Consolidate Support ServicesCommissioner Martin Makary told staff that plans are being developed to centralize HR, IT, travel and other functions, which were heavily impacted by the 1 April reduction-in-force.
US FDA May Consolidate Support Services After Extensive Cuts

2 weeks ago | insights.citeline.com | Derrick Gingery |Sue Sutter

US FDA May Consolidate Support Services After Extensive CutsCommissioner Martin Makary told staff that plans are being developed to centralize HR, IT, travel and other functions, which were heavily impacted by the 1 April reduction-in-force. Centralizing HR, communications and other services seemed inevitable after the FDA RIF targeted those areas. (Shutterstock)
US FDA May Consolidate Support Services After Extensive Cuts

2 weeks ago | insights.citeline.com | Derrick Gingery |Sue Sutter

US FDA May Consolidate Support Services After Extensive Cuts Commissioner Martin Makary told staff that plans are being developed to centralize HR, IT, travel and other functions, which were heavily impacted by the 1 April reduction-in-force. Centralizing HR, communications and other services seemed inevitable after the FDA RIF targeted those areas. (Shutterstock)
US FDA’s Rising First-Cycle Complete Response Rate Draws Congress’ Attention

2 weeks ago | insights.citeline.com | Sue Sutter

US FDA’s Rising First-Cycle Complete Response Rate Draws Congress’ Attention The House Appropriations Committee wants an analysis of how issues that led to CRLs could have been resolved within the first review cycle and seeks an agency crackdown on counterfeit GLP-1 agonists. House Appropriations Committee members want a briefing after the FDA's mifepristone review is completed. (Screenshot of House Broadcast)