hat tip @chuck_petty who knows *a lot* about the antibiotic scene, and who you should absolutely follow
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That chart is completely wrong. Although FDA only takes several months from drug APPLICATION to drug approval, FDA requires about 14 years research even before SUBMITTING the drug application. The idea that drug approval only takes several months is a FDA lie.
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I think its actually 14 and 10 years, but that includes the legal disputes: "New drug and device approval in the United States take an average of 12 and 7 years, respectively, from pre-clinical testing to approval."https://www.sciencedirect.com/science/article/pii/S2452302X1600036X …
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Could the fact that the US FDA takes on average 14 years to issue a new drug approval, and only after multi million dollar animal studies, whereas the EU and most of Asia only requires on average about 1.5 years account for some of the difficulties faced in biotech?
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Good point. However, EU has a great many drugs available well before the US. In fact, the FDA prohibits some drugs and devices entirely. Some drug and device manufacturers simply give up on the US market.
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"Time lag between [medical device] approval in Europe to approval in the United States (for those that were able to obtain FDA approval) was 3 to 7 years." This is from concept to administrative approval, incl all testing:https://www.sciencedirect.com/science/article/pii/S2452302X16300638#bib26 …
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1) Evidence? 2) Yup 3) Yikes!
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I'll secund 1, totally a thing, and quite annoying. People will not date you if you use condoms
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My kid got about one bad staph infection per month (cutaneous) and it was pretty terrifying to realize that we were down to about 2 antibiotics that would work.
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