The FDA’s Office of Generic Drugs (OGD) is set to launch a six-month pilot program designed to enhance communication and transparency with generic drug applicants. First announced by the FDA at the Association for Accessible Medicines’ GRx+Biosims conference in October 2023, the initiative is expected to roll out within the next month, according to OGD Director Iilun Murphy.
This program, a response to feedback from industry stakeholders, aims to provide earlier guidance on complex regulatory issues that typically cause delays in approvals. By addressing these challenges sooner, the FDA seeks to improve submission quality and increase first-cycle approval rates, as nearly 40% of generics currently require multiple review cycles.
As part of a broader FDA effort to streamline the generic drug approval process, this initiative will help manufacturers navigate regulatory hurdles and submit higher-quality applications. The pilot will be evaluated for its effectiveness in improving outcomes and providing industry with clearer, more timely guidance.
For more information about this initiative, visit the GRx+Biosims 2024 conference page