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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

Novavax Readies COVID-19 Vaccine Request For EUA, But How Much Longer Will The Door Be Open?

Availability of emergency authorization route in US depends upon lack of 'adequate, approved and available alternatives,' but as more vaccines make their way through the BLA process sponsors may find the EUA door slowly closing.

Coronavirus COVID-19 Vaccines

Pfizer First: Oral Antiviral Paxlovid Wins EUA As Merck’s COVID Pill Languishes At US FDA

Authorized for mild-to-moderate COVID-19 in patients 12 and older at high risk for severe disease, Paxlovid (nirmatrelvir/ritonavir) jumped ahead of Merck & Co./Ridgeback’s molnupiravir in the EUA queue for oral antivirals, with the latter possibly hung up by efficacy and safety concerns.

Coronavirus COVID-19 Review Pathway

Data Integrity: COVID-19 Impacted Studies Pose Unique Enforcement Risks

Move toward decentralized trials means sponsors may be working with naïve clinical investigators who lack experience, Greenleaf’s Cynthia Schnedar says; DoJ’s Gustav Eyler urges drug sponsors to look for oddities in clinical trial data and to voluntarily report potential misconduct.

Compliance Enforcement

Real-Word Evidence Generation System Will Be A Priority For Califf As FDA Commissioner

At his Senate confirmation hearing, Robert Califf said he wants to establish a system, built on electronic medical records, that can be used to more quickly confirm the benefits and risks of accelerated approval drugs.

Real-World Evidence Review Pathway

US FDA’s Overloaded Advanced Therapies Office Eyes Organizational, Communication Changes

Office of Tissues and Advanced Therapies seeks to optimize its organizational structure and adopt more group-level communications, instead of one-on-one interactions with sponsors, to keep up with the massive growth in cell and gene therapies, director Wilson Bryan says.

Gene Therapy Regenerative Medicine

Antisense Oligonucleotide Clinical Guidance Emphasizes Individualized Nature Of Treatment

US FDA’ s latest ‘n of 1’ guidance describes clinical considerations for INDs to support dosing and monitoring of an individual with a life-threatening genetic disease who is eligible to receive an ASO; recommendations apply only when a few patients may be candidates for treatment.

Personalized Medicine Rare Diseases
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