Public rarely knows full reason FDA rejects new drugs

Reuters, 16 June 2015
Author: Lisa Rapaport
“Drug companies generally don’t disclose all the reasons new medicines fail to win U.S. marketing approval, even though regulators often reject treatments over concerns about safety or effectiveness, a study finds. Researchers compared the details companies made public in press releases with confidential documents from the U.S. Food and Drug Administration known as complete response letters, which explain why a new medicine can’t be sold. Often, companies made no announcement when a drug was rejected, or omitted most of the reasons the FDA cited for denying approval, the study found.”
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