HBW Insight is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction
UsernamePublicRestriction

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

Patient-Reported Outcomes In Pediatric Cancer Trials Endorsed By US FDA Advisory Committee

Incorporation of the Ped-PRO-CTCAE instrument would help inform short-term tolerability and long-term effects of treatment, particularly newer immunotherapy agents, but there are logistical and operational challenges to overcome, advisory committee members said.

Pediatrics Clinical Trials

Fixed Combinations Of ‘Old Antibiotic’ Plus New Moiety Eligible For NCE Exclusivity, US FDA Says

A 2008 law that limited exclusivity for certain antibiotics to three years does not apply to Allergan’s Avycaz, which combines an approved old antibiotic active moiety and a new active moiety, CDER exclusivity board concludes.

Intellectual Property Legal Issues

Pfizer/BioNTech’s COVID-19 Vaccine Moves Into Adolescents; Adcomm To Weigh Broader Pediatric Issues

Emergency use authorization in 12-15 year-olds follows announcement of a June advisory committee meeting on pediatric data requirements, including the FDA’s criteria for younger children. Authorization for US adolescents has raised ethical questions about prioritizing this lower-risk group over hard-hit populations overseas.

Coronavirus COVID-19 Vaccines

Pediatric Cancer Trials: US FDA Panel To Weigh Use Of Real-World Data, Patient-Reported Outcomes

Advisory committee will discuss ways to encourage inclusion of the Pediatric PRO-CTCAE tool in cancer trials on 11 May, followed the next day by a discussion on real-world data sources that could inform the efficacy and long-term safety of pediatric cancer treatments.

Advisory Committees Pediatrics

ODAC Report Card: Six Takeaways From Accelerated Approval Reviews Of Checkpoint Inhibitors

US FDA’s expedited pathway remains alive and well in oncology, but ‘dangling’ indications may be subject to more regular public scrutiny going forward; negative votes for two of six indications reflected the influence of Oncology Center of Excellence director Richard Pazdur.

Advisory Committees Review Pathway

US FDA’s ‘Active Moiety’ Approach On NCE Exclusivity Codified Under Drug Pricing Legislation

Measure clarifies the meaning of new chemical entity by replacing the term ‘active ingredient,’ which encompasses esters and salts, with ‘active moiety’ as defined by the FDA; legal experts are skeptical the measure will generate cost savings and say it gives the agency wide latitude to make future changes in eligibility for 5-year exclusivity.

Legislation Pricing Debate
See All
UsernamePublicRestriction

Register