Final Days: Chinese Scientists Have Solved the DP Culturing Problem! (2014)
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I agree with you I think the whole world is fed who with Ba**** corrupt FDA trying to be the world boss. Its about time people told them to get stuffed and people around the world should start taking their business some where else. I for one would truly pay my business in a different country rather than those FDA Goons.
On the other hand, in the sixties, pharmacologist Frances Kelsey, Ph.D., M.D.,famous reviewer for the U.S. FDA refused to authorize thalidomide for market because she had concerns about the drug's safety. Her concerns were justified when it was proven that thalidomide caused serious birth defects in European countries where it was available. Kelsey's career intersected with the passage of laws strengthening the FDA's oversight of pharmaceuticals.
35YrsAfter also posts as CITNews and works at Dr. Cole's office
forhair.com
Cole Hair Transplant
1070 Powers Place
Alpharetta, Georgia 30009
Phone 678-566-1011
email 35YrsAfter at chuck@forhair.com
The contents of my posts are my opinions and not medical advice
Please feel free to call or email me with any questions. Ask for ChuckLast edited by 35YrsAfter; 03-05-2014, 08:06 AM.Comment
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Corruption and corporate money "influence" is a problem worldwide. The FDA like nearly everything else in life, is a mixed bag. For example, the FDA has its heroes and heroines. I might have spelled heroines, "heroins". Unfortunately more people die from legally prescribed drugs than illegally obtained substances.
On the other hand, in the sixties, pharmacologist Frances Kelsey, Ph.D., M.D.,famous reviewer for the U.S. FDA refused to authorize thalidomide for market because she had concerns about the drug's safety. Her concerns were justified when it was proven that thalidomide caused serious birth defects in European countries where it was available. Kelsey's career intersected with the passage of laws strengthening the FDA's oversight of pharmaceuticals.
35YrsAfter also posts as CITNews and works at Dr. Cole's office
forhair.com
Cole Hair Transplant
1070 Powers Place
Alpharetta, Georgia 30009
Phone 678-566-1011
email 35YrsAfter at chuck@forhair.com
The contents of my posts are my opinions and not medical advice
Please feel free to call or email me with any questions. Ask for ChuckComment
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Legit Reasons for Caution
35YrsAfter also posts as CITNews and works at Dr. Cole's office
forhair.com
Cole Hair Transplant
1070 Powers Place
Alpharetta, Georgia 30009
Phone 678-566-1011
email 35YrsAfter at chuck@forhair.com
The contents of my posts are my opinions and not medical advice
Please feel free to call or email me with any questions. Ask for ChuckComment
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There are legitimate risks that must be considered.
35YrsAfter also posts as CITNews and works at Dr. Cole's office
forhair.com
Cole Hair Transplant
1070 Powers Place
Alpharetta, Georgia 30009
Phone 678-566-1011
email 35YrsAfter at chuck@forhair.com
The contents of my posts are my opinions and not medical advice
Please feel free to call or email me with any questions. Ask for Chuck
15 years is total bullshit.Comment
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That's what safety trials are for. I'm not saying we should bypass all the trials and let biotechs have a free-for-all, my argument is that the average 10-15 years for a new drug to hit the market is unacceptable. Nearly all of us don't have 15 years to wait on a new treatment approved by the FDA... if even approved.
15 years is total bullshit.
1st is initial safety phase for one year.
2nd is large safety/efficacy phase for 2 years(part one is big group just for safety, then 2nd year is bigger group for efficacy if it passes)
after that maybe a limited release then extended. I just never understand when a company like say Histogen proves efficacy, but then they have to pay millions for a third phase just to get the same results.Comment
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The proof required for FDA approval should vary by the treatment and its approach. I would argue a topical that has some evidence it works like CB 03 01 poses much less of a risk then say a new immune system drug that is not similar to anything previously done. Require 2 phases for a less dangerous drug and 3 for more risky stuff. If you cant tell just make it the usual but some stuff just has a lot less risk then others.Comment
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The proof required for FDA approval should vary by the treatment and its approach. I would argue a topical that has some evidence it works like CB 03 01 poses much less of a risk then say a new immune system drug that is not similar to anything previously done. Require 2 phases for a less dangerous drug and 3 for more risky stuff. If you cant tell just make it the usual but some stuff just has a lot less risk then others.
Doesn't matter, USA isn't the only country in the world (thank god) so as I've said before, a strong push needs to be made to boycott the FDA and take your business elsewhere.Comment
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