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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

Don't Sleep On DTC Compliance: FDA Dings Zolpimist Superiority Claim Vs Ambien

Warning letter objects to webpage and meeting exhibit material for excluding any risk information and suggesting mist formulation is superior to oral zolpidem products.

BioPharmaceutical Regulation

Generic Abuse-Deterrent Opioids: Comparison To Brand Will Not Require Use Of Control

FDA final guidance recommends comparative pharmacodynamic studies for nasal and oral routes of abuse, simplifies statistical approach to show deterrence of generic is same as brand.

BioPharmaceutical Regulation

What Is Inter Partes Review?

A description of the patent challenge proceeding and how it differs from district court litigation.

Intellectual Property Legal Issues

How Comprehensive Do IPR Decisions Have To Be?

Supreme Court to consider whether Patent Trial and Appeal Board must address all patent claims challenged in an inter partes review petition.

BioPharmaceutical Policy

Will Inter Partes Review Go Away? Supreme Court Weighs Fate

Biopharma and generic industries stand on opposing sides in case that could eliminate the patent challenge proceeding. Interactive timeline covers IPR's five-year history leading to oral arguments Nov. 27.

Legal Issues Intellectual Property

Regenerative Medicine Clinical Trials: US FDA Supports Studies Comparing Multiple Agents

Draft guidance suggests comparing therapies for a rare disease to each other and active control, offers examples of novel efficacy endpoints and what therapies may qualify for breakthrough and RMAT designations.

BioPharmaceutical Regulation
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