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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

COVID-19 Vaccine Refresh For Boosters Only? US FDA Position On Primary Series May Have Shifted

FDA advisors will vote 28 June on whether an Omicron component should be included in new COVID-19 booster vaccines. Following WHO recommendations, the FDA may no longer also be looking to update the primary vaccine series at this time. 

Advisory Committees Coronavirus COVID-19

Drugs From Sponsors ‘Located in Russia,’ Would Be Barred From US FDA Review By House Funding Bill

Language of the amendment cleared by appropriators in response to the Russian war against Ukraine in FDA’s fiscal year funding bill is vague, making impact of the funding ban on industry unclear. Democrats supported the amendment but said they wanted to continue to work on language to avoid “unintended consequences.” FDA would get a 10% bump in non-user fee funds under the bill.

United States FDA

US FDA Leaves Pfizer’s Efficacy Data Out Of Under 5 EUA Due To ‘Data Maturity,’ Lack of ‘Confidence’

Moderna’s ‘more mature’ vaccine efficacy data in children under 6 get agency highlight due to what Peter Marks called a ‘confidence’ difference in the numbers, the but CBER chief also said differences between Moderna’s and Pfizer’s vaccines are ‘subtle’ in this age group.

Coronavirus COVID-19 Vaccines

Moderna, Pfizer Nab Unanimous Votes For Pediatric COVID Vaccines But Advisors Hint At Moderna Dosing Advantage

US FDA advisory committee members raised some concerns regarding Pfizer’s three-dose schedule for children under five, suggesting Moderna’s two-dose primary series may be preferred.

United States Advisory Committees

COVID Vaccines For 5 and Under: Pfizer Pivot To 3 Shots Leaves Meager Data Package Compared To Moderna

Pfizer’s decision to add a third shot to the primary vaccination series for children under five means it didn’t hit FDA’s goal of a median follow-up of two months post-vaccination – at least with blinded data – and the sponsor could only do a preliminary descriptive efficacy analysis since the study had not hit the protocol-specified number of COVID cases.

FDA Advisory Committees

Cancer And Accelerated Approval: FDA To Crack Down On Single-Arm Trials, Refractory Disease Focus

US FDA cancer chief Rick Pazdur plans to send industry to ‘rehab’ with Project Frontrunner, which will push for development of cancer drugs in randomized controlled trials in earlier disease. Goal is to reduce time of uncertainty between accelerated approval and confirmatory evidence.

Drug Approval Standards Drug Review
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