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FDA
FDA Dropping Requirement For 2 Studies For New Drug Approvals
A one-trial requirement will be the FDA’s new default standard,’ agency leaders said.
FRI FEB 20, AT 8:05 PM
The FDA has typically required two studies from companies seeking approval for most new drugs, although in recent years it has approved some drugs based on a single well-run trial.
“The FDA has demonstrated disease-by-disease flexibility and has granted approvals based on a single premarket study with confirmatory evidence. In some fields, such as oncology, single trials have supported the majority of drug approvals,” Dr. Marty Makary, the FDA’s commissioner, and Dr. Vinay Prasad, head of the FDA’s Center for Biologics Evaluation and Research, said in an article published on Feb. 18 by the New England Journal of Medicine.
https://www.zerohedge.com/medical/fda-dropping-requirement-2-studies-new-drug-approvals
trials by the company who made it and gave it to a company paid to evaluate it does not make it an independant valid research... of course it will be in their favor. why else would they send it to specific companies. pay back is good..
