FDA Issues Final Guidance To Advance Policies for Drug-Development Process
The US Food and Drug Administration (FDA) has finalized a guidance, Special Protocol Assessment Guidance for Industry, which provides drug manufacturers with information about the procedures and policies adopted by the FDA’s Center for Drug Evaluation and Research and Center for Biologics Evaluation and Research for special protocol assessment (SPA), a drug-development process.
SPA is a process in which sponsors may ask to meet with the FDA to reach agreement on the design and size of certain clinical trials, clinical studies, or animal studies to determine if they adequately address scientific and regulatory requirements for a study that could support marketing approval. An SPA agreement indicates concurrence by the FDA with the adequacy and acceptability of critical elements of the overall protocol design that are important to ensuring that the trial conducted under that protocol has the potential to support the product’s approval.
The FDA says this interaction between the FDA and the drug sponsors helps improve the quality of the clinical trials that may be used to support a future marketing application by providing drug developers with more opportunity to get feedback from the FDA on the design of clinical trials. This process can also allow sponsors and the FDA to agree on clinical trial designs and endpoints for trials that, if successful, can provide templates for future research. These interactions ensure that the FDA agrees with key protocol elements and help sponsors plan late-phase development. However, an SPA agreement between a sponsor and the agency does not guarantee the FDA will approve a future marketing application for the product based on the SPA protocol.
This guidance was finalized after incorporating public feedback on the revised draft guidance issued in 2016. The draft guidance was first issued in 2002. SPA was established under the Food and Drug Administration Modernization Act in 1997 and since then, more than 1,000 SPA agreements have been granted.