FDA has new leverage over companies looking for a quicker drug approval

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The Food and Drug Administration has new tools to hold drug companies accountable for promises they make about medications. But the agency has yet to show its hand in using this new power.

Following confirmatory studies that didn't prove Makena's efficacy, the FDA's Center for Drug Evaluation and Research recommended pulling the drug from the market in October 2020. But because the drugmaker didn't voluntarily withdraw the drug, a hearing to discuss Makena's potential withdrawal was required. It took two years for the FDA's advisory committee to meet, and members voted in favor of removing it from the market.

Still, the law doesn't outright require that studies confirming efficacy of a medication be underway at the time of approval. It only says FDA leaders"may require" it.

 

ขอบคุณสำหรับความคิดเห็นของคุณ ความคิดเห็นของคุณจะถูกเผยแพร่หลังจากได้รับการตรวจสอบแล้ว

You mean like genetic technology (vaccine) ?

Can we get an update on your covid lab leak is just a baseless conspiracy theory story?

Great, now hold Pfizer accountable for health issues related to the “vaccine” (I won’t hold my breath).

They HAVE been shown to be corrupt, inept, and frankly puppets for financial PROSTITUTION. They should be eliminated, shutter their doors

Dis you?

We would be better off without the D in FDA.

They approve drugs when they get made

🤦‍♂️

FDA will still be corrupt as usual

As they should have! regulations

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 /  🏆 144. in TH

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