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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.

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Companies Reveal Hurdles In Providing Drugs Via Expanded Access Programs

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Research & Development Clinical Trials

Current Pathways For Rare Disease Drugs Are Not Optimal, US FDA’s Califf Says

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Rare Diseases Review Pathway

Off-Label Communication: Industry Opposes Exclusion Of Phase II Data From US FDA’s Guidance

Revised draft guidance about scientific information on unapproved uses (SIUU) of medical products is impermissibly paternalistic and overly restrictive of scientific speech, MIWG says.

Advertising, Marketing & Sales Guidance Documents

Boosting Complex Innovative Designs In Clinical Trials: What The Pilots Show

Lilly representative suggests having more informal communication with FDA and consistent feedback across divisions. The firm had a positive experience participating in CID pilot with master protocol for chronic pain therapies.

Clinical Trials Research & Development

How Did US FDA Get Octapharma To Drop Its Suit?

Company sought court order to vacate agency’s approval of the fibrinogen products of three blood centers, saying they were wrongly exempt from clinical trials required for Octapharma’s Fibryga.

FDA Litigation

Payors Take Lead From FTC In Suing BI Over Its Orange Book Patent Listings For Inhalers

Class action complaint alleges Boehringer Ingelheim engaged in a ‘Respimat Orange Book scheme’ to thwart generic competition for Combivent Respimat and Spiriva Respimat that cost payors millions, if not billions, in overcharges.

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