ANDA Sponsors: Update Your FDA Contacts List
New policy allows more FDA staffers to answer certain questions about pending applications, rather than channeling them all through the regulatory project manager.
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Generic drug reviews during the first year of formal review goals cost 70% more than during GDUFA's inaugural year.
Generic drug user fee reauthorization talks remain on schedule and are expected to last about four months.
Often data was not available from FDA, CDC or the sponsor to answer subgroup, safety and other questions that could have influenced the outcome of the advisory committee meeting.