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.
Demand-related shortages are a relatively new problem, but the FDA maintains their tools can prevent or end them.