Brenda Sandburg
Senior Editor

Latest From Brenda Sandburg
The History Behind The Drug-Device Combos Targeted By FTC
Of the 16 products whose Orange Book patent listings have been challenged by the FTC, six have no generic competitors and two faced first generic launches this year. A review of their patent and pricing battles shows the difficulties in developing generics for these complex drugs.
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.
FDA Is ‘Getting More Aggressive’ In Going After Drug Efficacy Claims Outside Label
Regulatory experts note there has been an uptick in enforcement letters objecting to efficacy presentations in Rx drug promotions that are not consistent with FDA-required labeling. Panelists at FDLI meeting also discuss the use of real-world evidence in prescription drug promotion.
US Supreme Court Seems Convinced Purdue Bankruptcy Plan Should Go Forward
Justices acknowledged that the release of the Sackler family from civil liability is a boon for them but appeared averse to rejecting a plan that is supported by the vast majority of victims of the opioid crisis.
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.