Zdrowie i gospodarka · 19/03/1999

FDA Releases Draft Guidance on Formal Dispute Resolution Process for Drug and Biologics Disputes

The Food and Drug Administration (FDA) has made available a draft guidance document outlining procedures for resolving scientific and procedural disputes in the pharmaceutical industry, specifically those that cannot be resolved at the division level, and will be implemented by the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER).