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Printed By


Sue Sutter

Senior Editor

Washington, DC
Sue primarily covers US drug, biologic, vaccine and biosimilar regulation and policy across therapeutic areas, with an emphasis on advisory committee reviews, FDA approvals and use of expedited review pathways. Sue has reported on the prescription and over-the-counter drug industries since 1999 for various publications now under the Citeline umbrella, including Pink 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. She grew up in South Jersey and spends her free time watching youth sports, gardening, walking and hiking, although she'd rather be at the beach.

Latest From Sue Sutter

Preterm Birth Prevention Studies Need To Look Beyond Makena Endpoints, Experts Say

Gestational age and a binary, neonatal composite endpoint are insufficient to assess outcomes that are important to babies and families, clinicians and researchers say, suggesting development of continuous variables or scales with weighted components and a comparison of outcomes among newborns in gestational age ‘buckets.’

Drug Approval Standards Pediatrics

Clinical Trial Diversity Requires Sponsors Work With An Assortment Of Patient Advocates, Community Organizations

US FDA oncology officials are concerned that the entities sponsors are consulting in developing and implementing clinical trial diversity plans are not sufficiently diverse themselves and do not represent patients in underserved communities.

Clinical Trials Diversity & Inclusion

Adcomm Open Public Hearings Have Become Too Sponsor-Driven – US FDA's Pazdur

Oncology Center of Excellence Director Richard Pazdur says he would like to see more diverse views during the OPH session, not just individuals curated by the sponsor to present ‘a very positive picture’ of the drug. An upcoming ODAC meeting will have everyone in-person except the OPH speakers, public and press.

Advisory Committees Drug Review

Drug Advertising: NAD’s Clout In Rx Disputes Rising As It Builds Ties With Social Media Platforms, FDA

National Advertising Division’s voluntary, self-regulatory process is increasingly being used to vet competitor complaints over prescription drug ads. The group now has a reporting channel to Meta, which will take down disputed claims from social media sites, and is working to demonstrate the value of self-regulation to the FDA, NAD VP Brett says.

Ad Complaints Advertising, Marketing & Sales

Fighting Accelerated Approval Withdrawal Hinders Other Sponsors' Applications, FDA’s Pazdur Says

Resource-intensive withdrawal process means FDA reviewers are not able to work on other drugs, Oncology Center of Excellence Director Richard Pazdur says, citing the ‘arduous’ withdrawal of Pepaxto. Pazdur also says no one should be surprised that the FDA has begun issuing complete response letters when confirmatory studies are not sufficiently advanced.

Review Pathway Post Market Regulation & Studies

Data Integrity: US FDA Guidance Seeks To Head Off Bioavailability/Bioequivalence Study Problems

Ultimate responsibility for data integrity rests with applicant, even if study is contracted out; testing site management should build a culture of quality, says the guidance, which aims to address the high-profile data integrity problems that have plagued the generic drug industry.

Generic Drugs Regulation
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