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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

At Solicitor General’s Urging, Supreme Court May Take Up Patent Eligibility Dispute Riling Biopharma

Federal Circuit’s rulings on subject matter patent eligibility have fractured the court, the US government says in advising the high court to review American Axle v. Neapco to provide clarity. BIO, former PTO director Kappos and Sen. Tillis also urge Supreme Court to hear the case.

Intellectual Property Legal Issues

Ukraine War Could Spur Changes In The Clinical Trial Paradigm

Decentralized trials are way to help displaced Ukrainians remain in studies and could encourage greater participation from individuals in other countries, those overseeing sites in Ukraine say.

Clinical Trials Policy

Seeking To Provide ‘The Best Clarity Possible,’ ACIP Votes For COVID Vaccine Booster In Children 5-11

CDC advisory committee recommends Pfizer/BioNTech vaccine booster, but one member votes ‘no,’ citing concern that only 29% of children ages 5 to 11 have received the primary two-dose series and arguing the focus should be on additional vaccinations, not additional doses.

Advisory Committees Coronavirus COVID-19

US FDA Could Require Pediatric Cancer Drug Combo Studies Under Amended User Fee Bill

House Energy & Commerce Committee adds Give Kids a Chance Act to user fee reauthorization package during markup. Bill was modified to exclude provision giving the FDA authority to require preclinical studies.

Clinical Trials Pediatrics

FTC’s New Commissioner, Alvaro Bedoya, May Bolster Tougher Stance On Pharma Oversight

Democrats gain majority on Federal Trade Commission with Bedoya’s swearing in. His positions on technology and digital privacy suggest he will align with commissioners who have advocated stricter review of pharma mergers.

Leadership Enforcement

Accelerated Approval, Clinical Trial Diversity Provisions Left Out Of Senate User Fee Bill

Two of the most prominent features of the House package are not addressed in the Senate measure, which predominantly focuses on cosmetics, dietary supplements and laboratory developed tests. The absence of competing proposals suggests a smooth conference process.

User Fees FDA
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