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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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Latest From Brenda Sandburg

Do Consumers Understand TV Ads For Oncology Drugs?

US FDA plans to conduct a study to evaluate consumer comprehension of oncology indications in direct-to-consumer television advertising.

Advertising, Marketing & Sales Regulation

Eskata Video Ad Broadcast On The View Gets Rebuke From US FDA

Agency says superimposed text about risks and efficacy is overshadowed by "attention-grabbing before-and-after photographs" of patients treated with the seborrheic keratoses treatment.

Advertising, Marketing & Sales FDA

Opioid Public Meeting Will Focus On Approval Standards, Development Incentives

US FDA also seeking feedback on whether the agency needs new authorities to better regulate opioid products.

FDA Drug Approval Standards

New Opioids May Need Comparative Effectiveness Data For Approval

Draft guidance says US FDA will consider product's benefit-risk balance relative to approved analgesics; it is particularly interested in comparative efficacy and safety data.

Guidance Documents FDA

Postmarketing Commitments: Sponsors Often Do Not Publish Results Of New Clinical Trials

Only 15% of postmarketing commitments for drugs approved in 2009-2012 were for clinical trials and only half of these were published, study finds; authors call for US FDA to provide more trial information.

Post Market Regulation & Studies Clinical Trials

Will US FDA Remove Higher Strength Opioids From The Market?

Advisory committee members are divided on whether agency should restrict access to higher dose opioids, but most want option kept on the table.

Advisory Committees FDA
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