How does the approval process works?

Collapse
X
 
  • Time
  • Show
Clear All
new posts
  • deuce
    Senior Member
    • May 2013
    • 210

    How does the approval process works?

    Does anyone truly know how the approval process works. I did some research and it seems like explanations are all over the place with people saying it takes from 12-18 years to get a product approved. How long does it really take? With drugs like cb,sm, and him in the pipeline we could be waiting 6 more years for these products? I don't know. COudl someone who really understands this process please explain. All I could find was this chart. http://en.wikipedia.org/wiki/File:Dr...on_Process.jpg
  • hellouser
    Senior Member
    • May 2012
    • 4423

    #2
    Originally posted by deuce
    Does anyone truly know how the approval process works. I did some research and it seems like explanations are all over the place with people saying it takes from 12-18 years to get a product approved. How long does it really take? With drugs like cb,sm, and him in the pipeline we could be waiting 6 more years for these products? I don't know. COudl someone who really understands this process please explain. All I could find was this chart. http://en.wikipedia.org/wiki/File:Dr...on_Process.jpg
    I don't understand what the FDA does for 18 months to say 'OK' on a new treatment.

    Comment

    • macbeth81
      Senior Member
      • Sep 2014
      • 101

      #3
      The FDA is part of the United States Federal Government. That would explain why it takes 18 months to 'OK' a treatment.

      I would also be surprised if they even have qualified staff to make such judgments. My guess is submissions must proceed through several layers of "make work" government staff who rubber stamp them between nap time and game time, before reaching a contractor who actually performs the review.

      Comment

      • hellouser
        Senior Member
        • May 2012
        • 4423

        #4
        Originally posted by macbeth81
        The FDA is part of the United States Federal Government. That would explain why it takes 18 months to 'OK' a treatment.

        I would also be surprised if they even have qualified staff to make such judgments. My guess is submissions must proceed through several layers of "make work" government staff who rubber stamp them between nap time and game time, before reaching a contractor who actually performs the review.
        American tax dollars, HARD at work.

        It's no different in Canada though... ie; our emergency wait times at hospitals. There was a case of a guy waiting for ER for about 34 hours... dude ended up DYING before getting to see a doctor.

        Comment

        • Hicks
          Senior Member
          • Apr 2013
          • 291

          #5
          I think it's all about liability. Not fair to the public to rush a treatment into service then find out 5 years later that it kills people or doesn't do anything. You think the industry is corupt now, just think if the FDA or other entity wasn't involved. I work in a heavily regulated industry. It's hurry up and wait.

          I said this before that the cure might be out there but no one knows the dose, frequency etc to it. What if the cure is a product that histogen or one of it's sub companies has right now but it's used for skin care say Neocell from CellCeuticals? Please i'm just throwing that out there as an example. however to say it grows hair safely then it better grow hair and be safe.

          Comment

          • deuce
            Senior Member
            • May 2013
            • 210

            #6
            I just don't understand how Spencer and Joe from Staten Island say Bimatroprost may be available next year if it is still only in phase 2. I would say that it is because it is already out for eyelashes, but it is in phase 3 in eyelashes so why wouldn't that go straight to market after phase 2?

            Comment

            • Follicle Island
              Junior Member
              • Dec 2014
              • 20

              #7
              Doesn't Minoxidil already outperform Bim ?

              Comment

              • rdawg
                Senior Member
                • Jun 2012
                • 1019

                #8
                Originally posted by Follicle Island
                Doesn't Minoxidil already outperform Bim ?
                0.03% bim yes, we dont know how it performs against the dosage in phase 2B(1-10% solution)

                we find out next month

                Comment

                Working...