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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

Informed Consent: For COVID-Affected Studies, A Handwritten Document May Suffice

Under certain circumstances, potential clinical trial participants may be able to provide informed consent by writing on a blank piece of paper that they voluntarily agree to participate in a given protocol, and texting or emailing a photo of the signed document to the investigator, the US FDA says in its latest guidance update.

Coronavirus COVID-19 Clinical Trials

Informed Consent: For COVID-Affected Studies, A Handwritten Document May Suffice

Under certain circumstances, potential clinical trial participants may be able to provide informed consent by writing on a blank piece of paper that they voluntarily agree to participate in a given protocol and texting or emailing a photo of the signed document to the investigator, US FDA says in latest guidance update.

Clinical Trials Coronavirus COVID-19

US FDA, Industry Share Early Lessons From Complex Innovative Trial Designs Program

Timelines in the CID program are tight, and sponsors should have a ‘fully baked’ trial design before heading into their first meeting with the agency, industry reps say; agency needs more simulation data from participating sponsors earlier and is working to ensure continuity for firms after the second of two meetings allowed under the program.

Clinical Trials FDA

US FDA Will Leverage Current Clinical Trial Data In Deciding On Post-COVID Flexibilities

Oncology Center of Excellence’s Paul Kluetz says agency intends to explore the effects of decentralization, remote assessments and other approaches adopted mid-stream on safety evaluations, missing data and endpoint variability.

Clinical Trials Coronavirus COVID-19

Decentralized Trials Guidance May Reflect US FDA’s Lessons Learned During COVID-19

Work on guidance that was originally expected in 2020 continues as the agency and industry learn more about the utility and spectrum of decentralized trials as a result of the novel coronavirus pandemic.

Clinical Trials Coronavirus COVID-19

Going Virtual: GSK’s Multiple Myeloma Drug Belantamab Tapped For US FDA Online AdComm In July

Announcement of the 14 July Oncologic Drugs Advisory Committee meeting follows a successful, two-day trial run of the virtual format by the oncology pediatric subcommittee that featured a mix of prerecorded and live sponsor presentations and strict adherence to a call/response approach to ensure orderly conduct.

Advisory Committees Coronavirus COVID-19
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