Brenda Sandburg
Senior Editor

Latest From Brenda Sandburg
Pink Sheet Podcast: CAR-T Malignancy Reports, Background Music In DTC Ads, New No. 2 At US FDA
Pink Sheet reporter and editors discuss the FDA acknowledging reports of malignancies in patients who received CAR-T cell immunotherapies, the agency’s policy for using background music in direct-to-consumer advertising, and the FDA’s new incoming principal deputy commissioner.
FDA’s Orange Book Dispute Resolution Process May Grow Teeth With FTC Patent Listing Challenges
People have challenged patent listings more than 60 times in the past six years but it is up to new drug application holders to decide whether to revise or delist their submissions.
Background Music During Risk Segment Of Rx Drug Ads: FDA Explains Its Policy
Total ban on background music is unnecessary, agency says in denying KEI’s petition. FDA points to new ‘major statement’ rule and its previous letters objecting to a sponsor’s use of music in ads and says it will continue case by case analysis of ‘all of the elements’ in an ad.
FTC Campaign Against Orange Book Patent Listings Extends To Mylan’s Battle With Sanofi
Sanofi’s Orange Book listings for its insulin glargine product ‘can be viewed as one part of an overarching monopolistic scheme,’ FTC says in amicus brief.
FTC Campaign Against Orange Book Patent Listings Extends To Mylan’s Battle With Sanofi
Sanofi’s Orange Book listings for its insulin glargine product ‘can be viewed as one part of an overarching monopolistic scheme,’ FTC says in amicus brief.
Rx Drug TV Ads Must Present ‘Major Statement’ Simultaneously In Audio & Visual Segments
FDA’s final rule on the major statement in DTC ads includes additional standard for presenting a drug’s side effects and contraindications in a clear, conspicuous and neutral manner. Rule permits ‘creative elements’ during presentation, including upbeat music.