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FDA Finalizes Guidance on Drug-Related Apps

Original: FDA has finalized its guidance on apps related to drugs

The US Food and Drug Administration has finalized its guidance covering software applications related to drugs. The guidance clarifies the agency's regulatory expectations for app developers and pharmaceutical companies whose products interact with or support drug therapies. Industry observers and digital health companies are watching closely, since the rules affect compliance requirements for a fast-growing segment of medical software.

Why now: The FDA's final guidance sets binding regulatory expectations for a rapidly growing digital health sector.

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Evidence

• FDA has finalized its guidance on apps related to drugs · STAT

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