One of the big culprits of ANDA delays is perhaps the number of generics that exist for a particular drug.
Maybe one way for the FDA to streamline their approvals process is to place certain applications, for drugs where there are already generics in the market, into a "slow lane".
The FDA is primarily responsible to drugs in the US. There is an equivalent European authority and a Japanese authority, but obviously most rely on FDA approvals as the defacto standard. Just how many generics for a drug should be allowed?
The idea of a "slow lane" system should be based on how many generics there already are and maybe the size of the market.
Perhaps there should even be limits imposed on the number of generics allowed for a particular drug.
Just my thoughts.
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