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Sue Sutter

Senior Editor

Washington, D.C.
Sue is a senior editor with Pink Sheet, where she writes primarily about drug, biologic and biosimilar regulation, FDA advisory committees and product approvals.  She has reported on the prescription and over-the-counter drug industries since 1999 for various publications now under the umbrella of Informa Business Information, including Pink Sheet, “The Pink Sheet” DAILY, “The Tan Sheet” and Scrip.  Previously she worked as an editor for Mealey’s Litigation Reports (now part of Lexis-Nexis), writing about asbestos, toxic tort and fen-phen litigation.

Latest From Sue Sutter

Pink Sheet Podcast: Adcoms Too Emotional, Pushing Gene Therapy Science, Congress Gets UFA Update

Pink Sheet reporter and editors discuss whether emotion could be removed from US FDA advisory committees, adverse events and advancing science in gene therapy development, and Capitol Hill’s interest in the ongoing user fee negotiations.

Advisory Committees Gene Therapy

Gene Therapy Safety Issues Reflect Pushing Of The Scientific Envelope – FDA’s Marks

Recent adverse events are ‘speed bumps’ that need to be worked around, biologics center head Peter Marks says; Morgan Stanley’s Peter Hwang asserts high-profile safety issues have added to unpredictability of gene therapy development, dampening investor enthusiasm for the field.

Gene Therapy Regenerative Medicine

COVID-19 Vaccine Studies Should Look Beyond Neutralizing Antibodies To Assess Variants’ Impact

Cellular responses and other potential immune correlates of protection could be better measurements of efficacy, Janssen’s vaccine discovery head argues at BIO.

Clinical Trials Vaccines

COVID-19 Vaccines: Myocarditis Reports Could Slow Expansion Into Pediatric Age Groups

Concerns about cases of heart muscle inflammation occurring in older male adolescents and young men shortly after the second dose of Pfizer and Moderna mRNA vaccines hung over FDA advisory committee discussions on pediatric safety data requirements for COVID-19 vaccines; CDC’s ACIP will take up the myocarditis issue at an 18 June meeting.

Vaccines Coronavirus COVID-19

US FDA’s Most Controversial Drug Approval Decisions, From A To Z

Following accelerated approval of Biogen’s Alzheimer’s drug aducanumab in the US, we look back at 10 of the FDA’s most controversial drug approval decisions, from Addyi to Zohydro.

Approvals Drug Approval Standards

Cancer Trials: Patient-Reported Outcomes Should Measure Five Core Concepts, US FDA Says

Heterogeneity in PRO assessment strategies has lessened the regulatory utility of such data from cancer trials, the agency says; new draft guidance recommends systematic assessment of a core set of PROs in registrational studies using fit-for-purpose tools and includes examples of acceptable instruments.

Clinical Trials Guidance Documents
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