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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

J&J COVID-19 Vaccine Pause Expected To Be Brief, But Subsequent Use May Be Restricted

CDC’s ACIP likely to discuss criteria needed to lift pause and whether to recommend that the vaccine not be used in specific groups. Former CBER official says FDA and CDC will look at reports for other adenovirus vector vaccines, including J&J’s Ebola vaccine, and the biological plausibility that cases of rare blood clots are directly associated with the vaccine.

Coronavirus COVID-19 Vaccines

NCI’s Clinical Trial Accrual Is ‘Better’ Than Pharma Industry’s, Director Sharpless Says

NCI networks had vast under accrual in the past year, but Sharpless says industry has been affected to a greater degree. He says the institute also has been better at accruing minority patients.

Clinical Trials Coronavirus COVID-19

Health Care Providers Have Knowledge Gap On Biosimilars, Accelerated Approval

FDA’s 2019 survey of 2,000 providers finds 31% do not know what biosimilars are and 30% of primary care physicians do not know what an accelerated approval drug is. Another survey of low- or non-internet users finds a toll-free number is the best way for them to find information about a drug’s risks.

Advertising, Marketing & Sales Biosimilars

Pharma Companies Need To ‘Think A Little Bigger’ To Avoid Government Enforcement Actions

Industry executives note lessons learned from ‘fascinating’ approaches DOJ and states have taken in recent settlements, from restrictions on Novartis speaker programs to targeting McKinsey’s marketing advice. Chart includes details of 18 settlements since January 2020.

Legal Issues Enforcement

US FDA’s Rx Drug Promo Study Answers $798,000 Question

Viewers spend more time on print ads that have more lengthy important safety information or a brief summary but impact on understanding is unclear, OPDP study finds. Another study finds exaggerated images of drug benefits in TV ads unsurprisingly can mislead consumers.

Advertising, Marketing & Sales Compliance

Responding To Rx Drug Promo Violations: Tips From OPDP

US FDA's staff have sometimes worked late into the night to help sponsors meet deadlines and avoid errors in responding to a notice of violation. As is often the case, early communication helps avoid problems.

Advertising, Marketing & Sales Enforcement
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