FDA is like a company ran by hypocrate (hope i spelled it correctly). They use execuses that they wanted to help us from bad drugs etc... Which some of it is true but also they fall into protecting the bad drug makers as well. So in short they neutralise the system and neither party win. The patient will get his drug which will not cure him but will expand his life to a point and the drug makers keep making their money.
Ok, but if company will sell some drugs in "deragulated way" in one country won't FDA punish them and won't allow to sell in other countries ?
Where we are now it would be better total deregulation and patient taking responsability for whatever they want to do instead of the system we have now
i bet some countries have such deregulated system where these drugs could be used even if not approved
What makes you think will be approved in late 2018? rep9ac was supposed to be approved in 2013 :)
Stif2011 is there any thing on clinical trial that we know in India? Thanks!
its all a big business fraud....i bet if india starts producing new drugs they ll run like wildfire with new approvals....
"NDA could be filed in late 2017, and the FDA approval is in late 2018. " - one year for checking papers ?