Activity

  • Shachi replied to the topic Potential FDA Changes under Trump in the forum Introduction to Project Management 8 years ago

    It’s indeed a very interesting topic to debate upon. According to the latest data on time taken by FDA on the product approval varies from 6 to 10 months. Relaxing the regulation a bit would definitely expedite the whole process. But at the same time, we don’t want another thalidomide episode. Its going to be a big challenge to find an intermediate position in such a case. Its absolutely true that it might save some patients who are about to die in couple of weeks or months. But in reality, it might just add some extra months or years to their life instead of totally curing them until or unless it is some wonder drug which is again an illusion more than a reality. But i would say its definitely a good move if the FDA is using its power to prevent a really good product from coming into the market. So i would suggest that rather than relaxing FDA, another committee or body should be formed which can act as a watchdog on FDA instead.