FDA is no longer looking into whether the ephedrine-containing dietary supplement played a part in the death of 15-year-old Rosanna Porras. The Santa Barbara, Calif. county sheriff's department has concluded Porras died of a congenital heart condition called Bland-White-Garland Syndrome and not from taking Twinlab's Ripped Fuel. Although "coroners investigators cannot say with certainty that the Ripped Fuel product contributed to Rosanna's death, it could have aggravated the condition to her heart before and after the massive heart attack," the sheriff's department says. Porras collapsed at a soccer game and died April 9. During the autopsy, her heart showed signs of a massive heart attack...
Join thousands of industry professionals who rely on Pink Sheet for daily insights
Already a subscriber?
Advanz Pharma would have had to show that the European Commission’s decision to revoke Ocaliva’s conditional marketing approval risked causing serious and irreparable harm, according to lawyers from Van Bael & Bellis.
This is your final call to participate in the survey to better understand our subscribers’ content and delivery needs. The deadline is 20 September.
We are conducting a survey to better understand our subscribers’ content and delivery needs. If there are any changes you’d like to see in coverage topics, article format, or the method in which you access the Pink Sheet – or if you love it how it is – now is the time to have your voice heard.
A new pilot aims to take Brazil closer to ‘digital transformation.’
Clinical trial sponsors in the rare disease space face “big safety demands” from regulators, which can be challenging for those with limited resources. A CRO founder makes the case for “embedding automation” into the clinical trial process to keep pace with regulatory requirements.
The developers of the ChAdOx1 NipahB vaccine will be able to benefit from the early and enhanced support that the European Medicines Agency offers through its priority medicines scheme.
The termination of the HHS Secretary’s Committee on Human Research Protections closed an important forum for discussing pediatrics and pregnancy in clinical trial design, a former SACHRP chair said.
