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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GDUFA: Review Costs Continued To Climb Once Formal Review Goals Began
Generic drug reviews during the first year of formal review goals cost 70% more than during GDUFA's inaugural year.
GDUFA Stakeholder Deadline May Come After Negotiations Conclude
Generic drug user fee reauthorization talks remain on schedule and are expected to last about four months.
Califf Plans US FDA, NIH Collaboration On Postmarket Evidence Generation
NIH Director Nominee Monica Bertagnolli is on board with both agencies working to better determine how approved treatments work in the real-world, FDA Commissioner Robert Califf said.