FDA's Scrutiny of Drug Makers Abroad Faulted (Asia)
This article was originally published in PharmAsia News
Executive Summary
A preliminary report by the Government Accountability Office shows the U.S. Food and Drug Administration would inspect overseas drug manufacturers once every 13 years at its typical pace. In fact, the USFDA only has records of ever inspecting a third of the 3,249 foreign drug companies on its priority list. In 2007, the agency inspected 13 out of the 714 Chinese drug makers that may export to the U.S. Out of 410 Indian facilities that could be inspected, only 65 were observed this year. In light of these findings, U.S. pharmaceutical companies say overseas drug manufacturers should be held to domestic standards. By law, U.S. manufacturers must be inspected every two years. (Click here for more - May Require Paid Subscription
You may also be interested in...
Biogen Sees Improving Momentum In Slow Leqembi Launch
Sales of the company’s new drugs have a lot of growing to do to make up for older products’ declines, but Biogen highlighted signs of strength for new launches in its Q1 report.
Vivalink Partners With Rett Syndrome Research Trust To Accelerate Research In Rare Disease
Vivalink will provide ECG wearable technology to monitor patients in RSRT’s Vibrant study, which is aimed at assessing autonomic dysfunction in children with Rett syndrome.
Cidara Offloads Rezzayo, Will Focus On Universal Flu Preventative
Cidara conferred global rights to its novel antifungal to marketing partner, Mundipharma, while reacquiring a flu prophylaxis it licensed to J&J in 2021 and gaining $240m in new funding to back development.