FDA Finalizes Drug Development Process Guidance

Special Protocol Assessment Guidance for Industry aims to bring greater predictability and certainty in new medicine studies to support safety and efficacy.

The FDA announced April 13 that it has finalized a guidance that provides drug manufacturers with information about the procedures and policies adopted by the agency’s Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER) for special protocol assessment (SPA), called Special Protocol Assessment Guidance for Industry.

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.

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 innovative clinical trial designs and novel endpoints for pivotal 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. 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This guidance was finalized after incorporating public feedback on the revised draft guidance issued in 2016. The draft guidance was first issued in 2002.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.

“As part of our commitment to efficient review and approval of innovative medical products that meet the FDA’s rigorous scientific standards, the agency works closely with drug developers to help ensure the conduct of high-quality clinical studies that support a finding of safety and efficacy,” said FDA Commissioner Scott Gottlieb, M.D. “The guidance issued today provides a detailed overview of the Special Protocol Assessment (SPA) process. These agreements between the FDA and sponsors can improve the quality of the clinical trials submitted to the FDA as part of marketing applications and allow product developers to gain more predictability about the requirements they need to meet in order to demonstrate the safety and effectiveness of a new medicine. Special Protocol Assessments also make the FDA’s review of the application more efficient as thesubmitted data are more likely to have already met certain criteria in support of safety and efficacy.The SPA process can also help avoid the conduct of trials that will not be able to provide evidence that could support drug approval, making clinical research more efficient.”

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