Trump's FDA Chief May Implement Progressive Approval For Drugs
... ONeill has publicly supported proposals to do away with the FDAs requirement for phase 2 and 3 trials. Instead, he favors progressive approval of drugs and other medical technologies.
... The Japanese, though, saw the value of Eschenbachs plan. They now use it for regenerative medicine. Japan legalizes therapies following proof of safety. Once a drug is in use, companies can move to phase 4. This means they monitor their patients and disclose efficacy data regularly.
... Big pharma benefits a great deal from the status quo. ..
... But its also true that patients are put at risk because they are denied access to unapproved but effective drugs.
Also, we pay much more for available drugs because companies must recoup costs imposed by the regulatory system. How big are those costs? Estimates of the average cost of one new medicine range from $1 to $4 billion.
Another side effect of the current system is that many drugs never leave the lab.
These are drugs that could effectively treat serious illness but arent worth the cost of approval.
This is because the patient population is too small to recoup approval costs.
Induced Tissue Regeneration (ITR) has even greater potential.
ITR is an emerging technology that could reactivate the embryonic healing powers hidden deep in your DNA. It could restore lost limbs, broken spinal cords, or any other body part to youthful function. Eyes, hearts, joints, skin, and livers could be taken back in time using relatively simple compounds. ...
Egilsstađir, 18.12.2017 Jónas Gunnlaugsson
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Trump's FDA Chief May Implement Progressive Approval For Drugs
Jónas Gunnlaugsson
Jónas Gunnlaugsson, 18.12.2017 kl. 11:23
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