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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

Unjustifiable Delays In Generic Competition? Biopharma Contends There Is No Problem

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FDA Biosimilars

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Vanda complaint against US FDA says generic label is not the same as Hetlioz and omission of braille lettering will increase medication errors. Company seeks recall of Teva’s product.

Generic Drugs Legal Issues

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Coronavirus COVID-19 Vaccines

FDA Urged To Collaborate With USPTO On Orange Book Listings, Eliminate Patent Use Codes

Stakeholders suggest a variety of USPTO and FDA actions that could help ensure patents do not improperly delay generic and biosimilar competition.

Intellectual Property Legal Issues

FDA Urged To Collaborate With USPTO On Orange Book Listings, Eliminate Patent Use Codes

Stakeholders suggest a variety of USPTO and FDA actions that could help ensure patents do not improperly delay generic and biosimilar competition.

Intellectual Property Legal Issues

Can US FDA Share Drug Sponsor’s Information With Patent & Trademark Office?

Patent office could request information from FDA that is material to patentability, speakers at USPTO-FDA ‘listening session’ advise the agencies. Information exchange raises questions about trade secret protection and burdens on agencies.

Generic Drugs Biosimilars
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