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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

Court Rules More Trial Data Must Be Posted On ClinicalTrials.gov

Plaintiff Peter Lurie, former US FDA associate commissioner, expects results of hundreds of clinical trials of approved medical products will become available under ruling against HHS.

FDA Clinical Trials

Court Rules More Trial Data Must Be Posted On ClinicalTrials.gov

Plaintiff Peter Lurie, former US FDA associate commissioner, expects results of hundreds of clinical trials of approved drugs will become available under ruling against HHS; co-plaintiff sought eteplirsen study data.

FDA Clinical Trials

Court Rules More Trial Data Must Be Posted On ClinicalTrials.gov

Plaintiff Peter Lurie, former US FDA associate commissioner, expects results of hundreds of clinical trials of approved drugs will become available under ruling against HHS; co-plaintiff sought eteplirsen study data.

FDA Clinical Trials

Generics Firms Deterred From Continuous Manufacturing

Rutgers University professor testifies in support of bill directing the FDA to designate National Centers of Excellence in Continuous Manufacturing; other bills target generic labeling, orphan exclusivity and counterfeit devices.

Manufacturing Generic Drugs

Mallinckrodt's Opioid Resolution Through Generic Unit Bankruptcy May Be 'Test Case'

Mallinckrodt to pay $1.6bn and place its generics unit in bankruptcy under agreement in principle for US global settlement; six states are not on board, including New York, whose suit is still set to go to trial March 20.

Legal Issues Advertising, Marketing & Sales

Continuous Manufacturing: Cost, Lack Of Know-How Have Deterred Generic Firms, Prof Says

Rutgers University professor testifies in support of bill directing the FDA to designate National Centers of Excellence in Continuous Manufacturing; other bills target generic labeling, orphan exclusivity and counterfeit devices.

Manufacturing Legislation
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