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Brenda Sandburg

Senior Editor

New York, NY
Brenda covers FDA regulatory policy and legal issues, including patent suits, Supreme Court cases, and government investigations, as well as developments at the US Patent and Trademark Office and Federal Trade Commission. Between stints at the Pink Sheet, she was a reporter for America Lawyer Magazine and a daily legal newspaper in San Francisco where she won several awards, including first place in investigative reporting for an article about the emergence of patent trolls. She is based in New York City.

Latest From Brenda Sandburg

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Combination Products Generic Drugs

FDA’s Orange Book Dispute Resolution Process May Grow Teeth With FTC Patent Listing Challenges

People have challenged patent listings more than 60 times in the past six years but it is up to new drug application holders to decide whether to revise or delist their submissions.

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FDA Is ‘Getting More Aggressive’ In Going After Drug Efficacy Claims Outside Label

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Advertising, Marketing & Sales Real-World Evidence

US Supreme Court Seems Convinced Purdue Bankruptcy Plan Should Go Forward

Justices acknowledged that the release of the Sackler family from civil liability is a boon for them but appeared averse to rejecting a plan that is supported by the vast majority of victims of the opioid crisis.

Legal Issues Restructuring

Pink Sheet Podcast: CAR-T Malignancy Reports, Background Music In DTC Ads, New No. 2 At US FDA

Pink Sheet reporter and editors discuss the FDA acknowledging reports of malignancies in patients who received CAR-T cell immunotherapies, the agency’s policy for using background music in direct-to-consumer advertising, and the FDA’s new incoming principal deputy commissioner.

Drug Safety Advertising, Marketing & Sales

FDA’s Orange Book Dispute Resolution Process May Grow Teeth With FTC Patent Listing Challenges

People have challenged patent listings more than 60 times in the past six years but it is up to new drug application holders to decide whether to revise or delist their submissions.

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