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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.
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Opioid Spotlight: Trump Announces Plans For More Spending As Congress Introduces Two Dozen Bills

Administration also plans to roll out slate of proposals to decrease drug prices and bring discounts to patients.

Legislation Neurology

IND Safety Reporting: Stakeholders Tussle Over Which Adverse Events To Report, Proper Oversight Body

US FDA officials, drug sponsors discussing creation of library of adverse event rates.

Drug Safety Regulation

Swayed By Industry Opposition To 'Intended Use' Rule, FDA Definitively Delays Implementation

US FDA is considering calls to drop 'totality of circumstances' test and to clarify that mere knowledge of unapproved use does not constitute evidence the use was intended.

Advertising, Marketing & Sales Legal Issues

US FDA Wants To Know What Doctors Know About Abuse-Deterrent Opioids

Healthcare professionals will be asked about their knowledge of abuse-deterrent opioid formulations along with their views on prescription drug promotions.

BioPharmaceutical Regulation

Rx Drug Ads: New US FDA Studies Target Accelerated Approval Information

Upcoming research projects will look at presentation of FDA approval status, timing of disease awareness ads, and healthcare professional views.

Advertising, Marketing & Sales Regulation

Janssen Emphasizes Average Net Price Decline As Transparency Momentum Builds In States

Rebates, discounts drove Janssen's average net price down 4.6% in 2017 even as average list price increased 8.1%; transparency report emphasizes value-based contracts for prostate cancer, diabetes drugs.
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