Enforcement Updates in Brief
This article was originally published in The Gold Sheet
Executive Summary
FDA import alerts hit Chinese firms and Teva; EU GMP suspensions hit Bend Research and several Indian firms.
You may also be interested in...
FDA Warning Letter Slams Another Asian API Firm On Data Integrity
Data integrity warning letter to Chinese API maker reflects continuing focus of FDA enforcement efforts on the pharmaceutical industry's Asian supply chain.
Pharma Can Pursue Claims Against Providers For 340B Duplicate Discounts In Medicaid Managed Care, HRSA Says
The statement, which is part of a final rule on the 340B administrative dispute resolution process, could facilitate manufacturer efforts to seek repayments from hospitals in such cases.
The Aspirin Test For AI?
US FDA Commissioner Robert Califf tells Congress that regulators don’t have to know how artificial intelligence works in medicine, but must make very sure it actually does work.