CDER to resolve formal disputes at the center level

FDA Center for Drug Evaluation and Research Director Janet Woodcock said the Office of Executive Programs will now manage CDER's formal dispute resolution (FDR) program. The process allows sponsors of user fee drug and generics products to seek resolution of scientific and medical disputes that could not be resolved at the division level. Previously the program was managed by the Office of New Drugs because OND historically received more FDR appeals each year than the Office of Generic Drugs. However, Woodcock said the number of appeals within OGD has increased over the last four years and in 2017 exceeded the number of OND appeals. The move allows center-level management of the program. ...