Generics Bulletin 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

Brenda Sandburg

New York, NY
Brenda Sandburg is a senior writer who covers legal issues and FDA regulatory policy, with a particular focus on patents, biosimilars, and government investigations. She spent 10 years writing for legal publications between stints at The Pink Sheet and blends these experiences to provide in-depth analysis of events. An aspiring photographer, she enjoys taking photos to accompany news stories.

Latest From Brenda Sandburg

Biden To Give Away 10% Of US COVID-19 Vaccine Supply As He Mulls Call For Patent Waiver

President Biden announced plans to increase vaccination in the US as members of Congress and industry press the administration to take steps to expand global access to COVID-19 vaccines. BIO proposes an alternative to the TRIPS waiver that would expedite export of raw materials and manufacturing supplies.

Coronavirus COVID-19 Vaccines

US FDA Takes Star Turn In Recent Drug Ingredient Liability Lawsuits

Agency’s direct involvement in pharma product liability litigation is one of the most striking developments in the field over the past year; 16 cases in multidistrict litigation listed in chart showing status of settlements and upcoming bellwether trials.

Legal Issues Ingredients

FDA Panel Okays Keytruda’s Hepatocellular Carcinoma Indication, But Splits On Opdivo

In 5-4 vote, US FDA advisory committee recommends withdrawal of Opdivo’s accelerated approval for second-line treatment of HCC while unanimously supporting the indication in Keytruda pending outcome of ongoing studies.

Advisory Committees Post Market Regulation & Studies

GSK Loses Bid To Get US FDA To Change Zofran Label, But May Prevail On Preemption Defense Anyway

Agency denies GlaxoSmithKline’s citizen petition requesting review of information about Zofran’s use in pregnancy. But GSK says agency has ‘clearly communicated its position that birth defect warnings are not warranted for Zofran.’

FDA Safety

US FDA Takes Star Turn In Recent Product Liability Lawsuits

Agency’s direct involvement in pharma product liability litigation is one of the most striking developments in the field over the past year. Chart of 16 cases in multidistrict litigation shows status of settlements and upcoming bellwether trials.

FDA Legal Issues

Keytruda, Opdivo’s Retention Of Hepatocellular Carcinoma Indication May Depend On Ongoing Studies

US FDA advisory committee to consider whether new studies can take place of failed confirmatory trials to support accelerated approvals. The agency also wants the panel to consider the changing landscape of HCC following the approval of atezolizumab in combination with bevacizumab.

Advisory Committees Clinical Trials
See All
UsernamePublicRestriction

Register