+ Reply to Thread
Results 1 to 8 of 8
  1. #1
    Senior Member
    Join Date
    May 2013
    Posts
    200

    Default 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

  2. #2
    Senior Member
    Join Date
    May 2012
    Posts
    4,423

    Default

    Quote Originally Posted by deuce View Post
    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.

  3. #3
    Senior Member
    Join Date
    Sep 2014
    Posts
    101

    Default

    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.

  4. #4
    Senior Member
    Join Date
    May 2012
    Posts
    4,423

    Default

    Quote Originally Posted by macbeth81 View Post
    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.

  5. #5
    Senior Member
    Join Date
    Apr 2013
    Location
    USA
    Posts
    287

    Default

    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.

  6. #6
    Senior Member
    Join Date
    May 2013
    Posts
    200

    Default

    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?

  7. #7
    Junior Member
    Join Date
    Dec 2014
    Posts
    20

    Default

    Doesn't Minoxidil already outperform Bim ?

  8. #8
    Senior Member
    Join Date
    Jun 2012
    Posts
    1,019

    Default

    Quote Originally Posted by Follicle Island View Post
    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

Similar Threads

  1. Dutasteride nearing approval for Hairloss?
    By rdawg in forum Hair Loss Treatments
    Replies: 0
    Last Post: 10-22-2014, 11:05 AM
  2. Is Dut on track for approval for MPB
    By Dav7 in forum Hair Loss Treatments
    Replies: 2
    Last Post: 03-13-2014, 09:02 AM
  3. What is the process in getting Procepia?
    By Jakewheat in forum Hair Loss Treatments
    Replies: 1
    Last Post: 02-07-2014, 09:20 PM
  4. Replicel's approval for TSX Venture exchange
    By BDDFreak in forum Cutting Edge / Future Treatments
    Replies: 8
    Last Post: 01-05-2014, 10:01 AM
  5. Japan to offer fast-track approval path for stem cell therapies
    By ANW in forum Cutting Edge / Future Treatments
    Replies: 19
    Last Post: 08-16-2013, 08:48 AM

Posting Permissions

  • You may not post new threads
  • You may not post replies
  • You may not post attachments
  • You may not edit your posts

» IAHRS

hair transplant surgeons

» The Bald Truth

» Recent Threads

1800 graft repair case results by Dr. Lindsey
Yesterday 08:38 AM
Last Post By Dr. Lindsey
Yesterday 08:38 AM
Navigating the German Job Market as a Kenyan Citizen
11-04-2023 06:31 AM
Last Post By Keegan212
Yesterday 03:51 AM
DR HAKAN DOGANAY/ 4500 GRAFTS / Implanter Pen+FUE
03-26-2024 04:15 PM
Last Post By Hakan Doganay, MD
03-26-2024 04:15 PM
The Mane Event for Thursday, June 15th, 2023
06-15-2023 02:59 PM
Last Post By gisecit34
03-26-2024 08:05 AM