Zdrowie i gospodarka · 06/11/2017

FDA Releases Guidance on Formal Dispute Resolution Process for Sponsors

The Food and Drug Administration (FDA) has released a guidance document titled "Formal Dispute Resolution: Sponsor Appeals Above the Division Level" to provide industry and review staff with procedures for resolving scientific and medical disputes between the FDA's Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER) at the office or center level. This guidance supersedes previous versions issued in 2000 and 2015.