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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.

Latest From Brenda Sandburg

NCI Is Being 'Flexible' With COVID-19 Clinical Trial Protocols

At ASCO symposium on cancer care during the pandemic, NCI Director Ned Sharpless notes trial accrual at NCI's National Clinical Trials Network dropped by half in March and April.

Coronavirus COVID-19 Cancer

US FDA Waives Warning Cap Requirement For Neuromuscular Agents As Demand Outranks Safety Worries

COVID-driven supply shortages were both the cause of and solution to production deficiencies for manufacturers of neuromuscular blocking agents; US FDA is permitting Mylan, Gland, and Fresenius Kabi to distribute vecuronium bromide and rocuronium bromide even though they do not have the paralyzing agent’ warning on the caps since the products are in high demand at ICUs. The appropriately embossed caps were unavailable due to supply chain disruptions caused by the pandemic.

Coronavirus COVID-19 Drug Safety

Keeping Track: Tauvid, Oriahnn, Artesunate Clear US FDA, Along With Trio Of Pediatric Approvals

The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker.

Approvals US FDA Performance Tracker

REMS In The Time Of COVID-19: ACLU Sues FDA Over Abortion Pill Access

Medical and advocacy groups claim FDA is requiring women to fill prescriptions for Mifeprex in person while waiving REMS requirement for in-person visits for other drugs.

Coronavirus COVID-19 FDA

Patent Owners Would Get Better Shot At Quashing IPR Petitions Under USPTO Rule

Proposed rule would eliminate petitioner advantage when patent board is deciding whether to institute inter partes review of patent claims.

Intellectual Property Policy

USPTO Allows Accelerated Path For COVID-19 Products Across Medical, Health Care Sectors

USPTO pilot program aims to examine applications for COVID-19 products subject to approval by FDA within 6 to 12 months. Prioritized examination is available solely for small entities and would save them $2,000.

Intellectual Property Coronavirus COVID-19
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