Ortho-McNeil Faces $150 Mil. Wrongful Death Suit Over Ortho Evra
This article was originally published in The Pink Sheet Daily
Executive Summary
Lawsuit alleges 17-year-old woman died from blood clots as a result of wearing the Ortho Evra patch.
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Use QbD to Get Through Rough Patch, FDA Tells Transdermal Makers
FDA officials say that there are “scientific gaps” in how transdermal patches are developed, manufactured and regulated, and urged manufacturers to adopt quality- by-design methods to help bridge these gaps and to better ensure product quality and safety.
Use QbD to Get Through Rough Patch, FDA Tells Transdermal Makers
FDA officials say that there are “scientific gaps” in how transdermal patches are developed, manufactured and regulated, and urged manufacturers to adopt quality- by-design methods to help bridge these gaps and to better ensure product quality and safety.
Ortho-McNeil Conducting Additional Studies To Assess Ortho Evra Blood Clotting Risks
The firm updated labeling to include a new bolded warning regarding increased hormone exposure with the patch versus oral contraceptives.