I feel that the recent changes in the filling requirement for abbreviated new drug applications brought about by the FDA will have a very strong impact on the small and medium companies because it not only increases cost but also stretches the time for filing. All their already stretched resources will be stretched further and that might lead to some companies selling off or merging in order to survive. This will surely have a negative effect on the CROs that serve that market. Only the very best will survive because the sponsors will not want to take any chances on the delivery from the CROs. I believe that the 4-6 quarters beginning 2014 will see a change in the landscape.
– Apurva Shah, Group Managing Director, Veeda Clinical Research
