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Sarah Karlin-Smith

Sarah is a senior writer at the Pink Sheet, specializing 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. 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.

Latest From Sarah Karlin-Smith

As FDA Advisers Grow Comfortable With EUAs, Harder Decisions On J&J’s Vaccine Fall To States, Individuals

J&J’s COVID-19 vaccine sails through its US FDA advisory panel, but that just means the subpopulation efficacy questions need to be wrestled with by other public health space, as CDC and the states must figure out the best way to distribute multiple vaccines with differing efficacy profiles, regimens and storage requirements.

Coronavirus COVID-19 Advisory Committees

From Trial Hold To Post-EUA Surveillance: FDA Wants J&J To Monitor COVID-19 Vaccine Data For Clots

Safety data does not look to be a barrier J&J vaccine’s authorization, but FDA says it will recommend surveillance for further evaluation of thromboembolic events. The agency says it currently cannot rule out a causal relationship with the vaccine. One of these cases prompted a study hold last fall.

Coronavirus COVID-19 Vaccines

FDA Commissioner Race: Biden Team Trying To Woo Reluctant Dems On Woodcock While Exploring New Options

The White House is trying to overcome some Senate Democrats’ opposition to Janet Woodcock as US FDA commissioner, while also looking for other candidates for the job. Josh Sharfstein, long thought to be Woodcock’s main competition, is not a strong contender.

FDA Leadership

US FDA Commissioner Race Shrinks And Widens: Biden Team Trying To Woo Reluctant Dems On Woodcock While Exploring New Options

White House is trying to overcome some Senate Democrats’ opposition to Janet Woodcock as FDA Commissioner, while also looking for other candidates for the job. Josh Sharfstein, long thought to be Woodcock’s main competition, is not a strong contender.

FDA Politics

US FDA Commissioner Race: Transparency Comes To Forefront With Study Of Refuse-To-File Letters

Of the two main contenders to lead FDA, Josh Sharfstein is seen as much more likely to open up review decisions to public scrutiny, while Janet Woodcock might be a vote for the status quo and more deferential to industry concerns.

FDA Politics

Pink Sheet Podcast: Dsuvia Warning Letter, Refuse-To-File Impact, CDER’s COVID Workload

Pink Sheet reporters and editor discuss the issues surrounding an FDA warning letter on Dsuvia promotion, an expected jump in CDER coronavirus-related workload, and a study of refuse-to-file actions.

Coronavirus COVID-19 Review Pathway
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