During the FDA approval process, companies often hit roadblocks with FDA. These can be caused by scientific disagreements, new or evolving regulatory requirements, or even unexpected patent certification or exclusivity issues. Unless resolved quickly, these types of problems can significantly delay approval of a company’s application.
FDA offers a wide variety of dispute resolution processes, both formal and informal, to resolve disagreements between FDA and an applicant and to restart stalled development programs. Because each pathway is different, it is important for companies to carefully assess which is best suited to the situation at hand. Some dispute resolution processes include strict timelines, others require companies to first jump through certain procedural hoops, while still others allow broad participation by different components within the Agency – or even by experts outside the Agency.
Scott Lassman has deep experience utilizing FDA’s dispute resolution procedures to successfully mediate disagreements between FDA and applicants in a timely manner. He has helped companies resolve disputes involving many different application types, including New Drug Applications (NDAs), Abbreviated New Drug Applications (ANDAs), 505(b)(2) applications, Biologic License Applications (BLAs), and section 351(k) biosimilar applications (aBLAs). His experience spans all types of dispute resolution procedures, both formal and informal. For example, he recently assisted companies preparing formal dispute resolution requests using the BsUFA and GDUFA dispute resolution processes. Scott also has experience resolving procedural disputes with the Ombudsmen in CDER and CDRH.