It appears sponsors are still learning what rises to the level of a pre-ANDA meeting with the US FDA.
During the first six months of reauthorized generic drug user fee program, the agency received 31 requests for meetings through...
Pre-ANDA Meetings Proving Tough To Get – Nearly Half Of Requests Denied
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During first half of fiscal 2018, US FDA only granted 16 of 31 pre-ANDA meeting requests, but said it was to ensure meetings were productive.
Learn what's happening at the US FDA. On the go.
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