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Sarah Karlin-Smith

Senior Writer

Washington, DC

Sarah specializes in the policy and politics that affect the pharmaceutical industry. She covers the US Food and Drug Administration, Centers for Medicare and Medicaid Service and Congress and other parts of federal and state government. Her work explores how government policies influence how drugs are developed and approved, what diseases are prioritized by scientists, and who gets access to medicines and at what cost. Sarah has covered health care since 2011. Prior to returning to the Pink Sheet in March 2020, she covered health policy at Politico for five years. She is a regular panelist on the Kaiser Health News 'What the Health' podcast. Sarah was selected for and attended a 2018 International Women’s Media Foundation reporting fellowship in Rwanda. In 2016, she attended Harvard Medical School’s media fellowship on bioethics and, in 2014, was an Association of Health Care Journalists-National Library of Medicine Fellow.

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AI And Postmarket Surveillance: A Signal To Noise Challenge

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Pediatric Study Plans Should Be Made Public, FDA’s Oncology Advisers Say

The push for more transparency so researchers are not unnecessarily duplicating or competing for the same small pool of patients raises a problem that goes beyond the RACE Act, FDA officials said.

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US FDA Focuses On Labs, Concomitant Medication To Avert Needless Clinical Trial Exclusions

The FDA is pushing sponsors away from template exclusion criteria to highly tailored drug- and trial-specific eligibility requirements in order to widen the patient pool eligible for studies.

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More Pediatric Cancer Trials Conducted Due To RACE Act

Initial data looks promising as the FDA’s pediatric oncology subcommittee is set to discuss how recent legislative changes have impacted pediatric cancer drug development. 

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US FDA Looking To Modernize Clinical Trial Regulations To Spur ‘Evolution’ In Research

The Center for Drug Evaluation and Research’s new Center for Clinical Trial Innovation (C3TI) may lead a “targeted” effort to update the FDA’s regulatory framework given advances in trial design and execution, CDER Director Patrizia Cavazzoni said. Industry already has asks.

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