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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

Off-Label Use Final Rule: US FDA Declines To Focus Solely On Promotional Claims

In final rule describing the types of evidence the agency will consider in determining the ‘intended use’ of a product, FDA rejects industry requests to exclude ‘circumstances surrounding distribution’ and product design or composition.

Advertising, Marketing & Sales Enforcement

Bills To Speed Generic Entry Once Again Clear Senate Judiciary Committee

Legislation to prevent pay-for-delay deals, product hopping and sham citizen petitions, and to require the FTC to study the role of pharmacy benefit managers in the drug supply chain get unanimous committee vote. They may have a good shot at passage given recent actions by President Biden and the FTC, and bipartisan interest in drug pricing.

Legislation Pricing Debate

Drug Pricing Measures Clear US Senate Judiciary Committee

They may have a good shot at passage given recent actions by President Biden and the Federal Trade Commission, and bipartisan interest in drug pricing. 

Pricing Debate Legislation

GSK’s Shingrix Vaccine Can Reach Millions More

The shingles vaccine could potentially be used in about three million immunocompromised people, according to GSK, but CDC’s advisory committee will weigh in with recommendations.

Approvals Vaccines

Janssen’s COVID-19 Vaccine Should Continue To Be Available, CDC Panel Concurs

Benefits of the one-shot vaccine outweigh risk, ACIP members agree. One member says he supports its availability but would personally recommend mRNA vaccines instead.

Advisory Committees Coronavirus COVID-19

J&J, Distributors May Be Free Of Opioid Litigation If Enough States Sign On To $26bn Settlement

NY AG has ‘no comment’ on whether criminal charges will be pursued against company executives; NC AG predicts ‘north of 40 states’ expected to accept settlement and would then need to convince municipalities to come on board. States with ongoing litigation against manufacturers may opt for jury trial instead. 

Legal Issues Advertising, Marketing & Sales
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