In Vivo 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

Rare Pediatric Disease Designation Requests Skyrocket Ahead Of Voucher Program’s Sunset

US FDA received 110 designation requests in July, a high mark that reflects the 60 days needed to review such requests ahead of the 30 September statutory expiration; agency is allowing email submission of RPD and orphan drug designation requests during the COVID-19 pandemic and expects to roll out an online portal for orphan designation requests later this year.

Review Pathway Rare Diseases

COVID-19 Vaccines: US Distribution Plans Include ‘Data Lake’ For Centralized Tracking

Most vaccines will be distributed centrally by McKesson, but those with ultra-cold storage requirements will be shipped directly from the manufacturer to the vaccination site. Data exchange system will enable public and private databases to talk to each other and help ensure individuals receive timely revaccination with a second dose of the same vaccine regardless of location.

Coronavirus COVID-19 Vaccines

A Matter Of Precedent: US FDA Sometimes Labors Under Weight Of Unpopular Or Unfavorable Decisions

As agency observers wonder whether and how political considerations will impact the timing of a COVID-19 vaccine approval or authorization, the Pink Sheet looks at instances through the years where agency staffers found themselves operating under precedents with which they disagreed or that didn’t work out as expected.

FDA Coronavirus COVID-19

Gene Therapies: US FDA Clarity Needed On ‘Sameness’ Determinations For Products From Same Vector Class

Agency also should better define, and provide examples of, the types of minor differences and additional features that would affect orphan drug designation and exclusivity determinations, industry sponsors say in comments on January draft guidance.

Gene Therapy Rare Diseases

Real-World Data: US FDA Gets 2 Out Of 10 In Abernethy’s Self-Assessment Of COVID Usage

But principal deputy commissioner gives FDA an ‘8 or 9 on vision’ of how to use RWD to address the pandemic and other challenges. The low ‘execution’ score is due to the large amount of effort needed to understand what datasets are available, how they can be used with confidence and what questions they can answer, Abernethy says.

Real-World Evidence Coronavirus COVID-19

US FDA Panel Rejects Trelegy Ellipta COPD Mortality Claim; Worries Include Potential Overuse

Survival benefit seen in GlaxoSmithKline’s IMPACT study may be due to negative effects of abrupt withdrawal of inhaled corticosteroids for some patients instead of benefits of the triple-combination therapy itself, advisory committee members said.

Advisory Committees Drug Review
See All
UsernamePublicRestriction

Register