FDA Releases Resources Planning Report
The agency’s plan outlines its approach to implementing medical product programs and the use of financial resources.
On April 4, 2018, FDA released a report, developed in consultation with PricewaterhouseCoopers LLP, that outlines the agency’s use of user-fee funding, its plan to modernize its time-reporting approach, and the development of its resource forecasting capability. The plan also includes organization of business processes and support models.
The report states, “As the science of product development and regulation has grown increasingly complex, FDA’s user fee programs have also grown both in the scope of activities and the volume and complexity of submissions. Taken together, this growth has increased the operational demands on the agency. To help ensure that the agency is making optimal use of its financial resources to maximize its ability to efficiently and effectively deliver on its commitments to the public, the agency has committed to developing a resource capacity planning capability and to modernizing its time reporting approach. Through the development of these capabilities, FDA will build more systematic, data-driven, and repeatable processes to better understand and anticipate its current and future resource demands. This will enable the agency to more proactively ensure its organizational components are optimally resourced.”
According to the report, FDA will compare actual resource utilization to forecasted resource utilization. The agency hopes “to improve its resource forecasts, prioritize its existing resources, and develop proactive plans to acquire the roles and skills it will likely require. The information will also help develop financial forecasts to better predict use of financial resources to support the user fee programs.”
Source: FDA
Regeneron Treatment for Multiple Myeloma Gets Conditional Marketing Approval from EC
April 29th 2025The indication is specific to patients who have received at least three prior therapies, including a proteasome inhibitor, immunomodulatory agent, and anti-CD38 monoclonal antibody, and have demonstrated disease progression on the last therapy.
MHRA Approves GSK Therapy Combinations for Multiple Myeloma
April 21st 2025Belantamab mafodotin is approved in combination with bortezomib plus dexamethasone in patients who have had at least one prior therapy, and in combination with pomalidomide plus dexamethasone for those who have had a prior therapy including lenalidomide.
