US FDA Hoping To Solve Drug-Software Issues With Digital Health Working Group
As more applications include software components, group wants assessors to apply best practices from CDRH to CDER whenever possible.
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New draft guidance allows electronics or software that will be used across multiple combination products to be submitted as a Type V drug master file, potentially streamlining the assessment process.
A COE modeled after the Oncology Center of Excellence, which stakeholders had proposed, is not in the works, but rather a more virtual structure.
As more sponsors begin using RWE, the agency is establishing procedures and training to ensure assessors consistently apply policies.