The U.S. Food & Drug Administration (FDA) on Monday declined to approve two cancer treatment drugs developed by drugmakers who tested their products mainly in China. The federal agency’s rejection is a sign of an increasingly tough U.S stance on drugs being tested solely in China, after some drugmakers moved to save costs by conducting clinical trials only in China. The FDA sent Complete Response Letters (CRLs) to Hutchmed Inc. and Coherus BioSciences Inc. on Monday in response to the biotechnology companies’ New Drug Applications (NDAs) to sell their drugs in the U.S. market. The rejection marks the second time the federal agency has rejected drugs tested in China this year. ...
Source: https://www.theepochtimes.com/fda-decli ... 41047.html
FDA Declines to Approve 2 More China-Tested Drugs
-
claireokc
- Posts: 10998
- Joined: Wed Dec 01, 2021 11:40 pm
- Location: Deep in the Heart of Soonerland
- Has thanked: 2 times
- Contact:
FDA Declines to Approve 2 More China-Tested Drugs
"America needs a brushfire, a moral and spiritual brushfire. And brushfires burn from the bottom up." ~ Bob Woodson