US FDA cites Bayer for Yaz TV commercial violations
This article was originally published in Scrip
Executive Summary
Two television commercials forBayer Healthcare's Yaz (drospirenone plus ethinylestradiol) broaden the oral contraceptive’s indication, overstate its efficacy and minimise risks, the US FDAhas said in a warning letter.
You may also be interested in...
US FDA Aims For More Timely Reviews Of Rx Drug Launch Promotions
New review process planned to launch next year. FDA officials and industry reps note re-emergence of FDA enforcement actions targeting internet-sponsored links.
At Tofersen Panel Review, US FDA Shined A Light On Internal Differences Of Opinion
Agency’s presentations on Biogen/Ionis’ ALS drug included differing viewpoints from the statistical and clinical pharmacology teams; the transparency and emphasis on a multidisciplinary review approach may reflect lessons learned from missteps at the Aduhelm panel review in 2020.
BrainStorm’s ALS Treatment NurOwn, Filed Over Protest, Will Get US FDA Panel Review
A November 2022 refuse-to-file letter cited clinical and statistical issues for the stem cell therapy, which failed its Phase III clinical efficacy endpoint. However, BrainStorm has consistently asserted that NurOwn demonstrated benefit in patients with less advanced disease at baseline, and it is encouraged by regulatory flexibility FDA recently has shown for the neurodegenerative disease.