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

PhRMA Sues To Block HHS Drug Importation Rule Citing Security, Safety, First Amendment Concerns

Complaint lists host of problems with implementation of the rule that allows states to sponsor programs to import certain prescription drugs from Canada; at least six states have enacted legislation to sponsor these programs.

Market Access Intellectual Property

Sanofi Grapples With Pandemic, Growing Clinical Trials, Implementing Acquisitions

Sanofi R&D head John Reed says the company has kept 95% of patients on its nearly 400 clinical trials, started 59 studies, and benefited from its in-house drug supply management.

Coronavirus COVID-19 Clinical Trials

Rx Drug Promotion: Potential Enforcement Worries

Pitfalls of using third-party hubs for reimbursement assistance, sharing preapproval data with patient groups, and promoting biosimilars with labeling carveouts are among the concerns noted by panelists at FDLI conference.

Advertising, Marketing & Sales Biologics

Pharma Companies Urged To Stop In-Person Speaker Programs In HHS OIG ‘Special Fraud Alert’

Companies should consider alternatives to in-person physician presentations given the risk of kickback violations, OIG says. Concerns addressed in Novartis corporate integrity agreement are broader than that case, Chief Counsel to the Inspector General Greg Demske explains in an interview.

Advertising, Marketing & Sales Enforcement

Will Aducanumab Join List Of Drugs Approved By US FDA Over Advisory Committee Opposition?

A look at drugs the agency approved despite an advisory committee vote not to do so and how they compare to Biogen’s Alzheimer’s disease drug aducanumab.

Advisory Committees Drug Review

US FDA Aims For More Timely Reviews Of Rx Drug Launch Promotions

New review process planned to launch next year. FDA officials and industry reps note re-emergence of FDA enforcement actions targeting internet-sponsored links.

Advertising, Marketing & Sales FDA
See All
UsernamePublicRestriction

Register