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/...
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/...
09:58 AM - Feb 21, 2026
Only people mentioned by KrisWilliams in this post can reply
Ingrid Colby
@ingajana
22 February, 10:36
In response Kris Williams to her Publication
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..
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Ana McMurry
@2GreenThumbs
21 February, 10:17
In response Kris Williams to her Publication
FDA is a Vaccine company, and their New word for vaccines is Biologics.
People NEED to stop referencing the FDA as something "good". They arent. FDA is worthless evil and saying FDA approved on any label means the product in question is crap.
People NEED to stop referencing the FDA as something "good". They arent. FDA is worthless evil and saying FDA approved on any label means the product in question is crap.
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ol_ cowboy
@ol_cowboy
21 February, 10:37
In response Ana McMurry to her Publication
Kind of like how WHO had nothing to do with "health", but instead a lot to do with taking over the World for the Nazi World Order.
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Elliott Schmeling
@ElliottSchmeling
22 February, 01:30
In response Ana McMurry to her Publication
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