Federal Register Notice: FDA is making available a draft guidance entitled Formal Dispute Resolution: Appeals Above the Division Level. It provides recommendations for industry on the procedures in the CDER and CBER for resolving scientific and procedural disputes that cannot be resolved at the division level. It describes procedures for formally appealing such disputes to the Office or Center level and providing information to assist FDA officials in resolving the issue(s) presented. To download this guidance, click here. To view this notice, click here.