Demographic data often missing in pivotal trials in Europe; FDA sends warning over falsified data in contract testing lab

Taking stock of the drug industry, from the lab to the medicine chest ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ 

STAT+: Race is often overlooked in key clinical trial data used to win new drug approvals in Europe By Ed Silverman Molly Ferguson for STAT Just two-thirds of the pivotal clinical trials that were used to win prescription drug approvals in Europe reported data on participant race. Read More STAT+: FDA warns Miami University contract testing lab over falsified data, poor quality control By Ed Silverman Andrew Harnik/AP "The results are not reliable, reportable, or suitable to support the quality of heparin drug or drug products," the FDA wrote to the school. Read More STAT+: Congress moves toward reforming FDA accelerated approvals, but with pharma-friendly concessions By Nicholas Florko Zach Gibson/Getty Images House lawmakers are moving a little closer toward cracking down on drugmakers that game the FDA’s accelerated approval pathway. Read More Sponsor content by STAT Events May 24 | The STAT Health Tech Summit Join us virtually, or in San Francisco, as we convene experts from Amazon Lab126, Ascension, Google Health, and more to discuss the next big innovations in health tech. We'll cover everything from patient data to AI to telemedicine. Get your ticket here. Opinion: Listen: How should doctors treat chronic pain in the wake of the opioid crisis? By Patrick Skerrett Clinicians walk a tightrope when trying to help people living with chronic pain. Two physicians describe what it's like. Read More Wednesday, May 4, 2022       1 Exchange Pl, Suite 201, Boston, MA 02109 ©2022, All Rights Reserved. I no longer wish to receive STAT emails Update Email Preferences | Contact Us | View In Browser