Formal Dispute Resolution Guidance Under Section 505G of the FD&C Act Issued Today
The FDA has issued a final Guidance for Industry titled Formal Dispute Resolution and Administrative Hearings of Final Administrative Orders Under Section 505G of the Federal Food, Drug, and Cosmetic Act (here). It provides guidance for sponsors and others on dispute resolution and hearing processes with the Center for Drug Evaluation and Research (CDER) once the […]
