FDA to modernize 'out-of-date' combination drug regulations

16 May 2018

The US Food and Drug Administration (FDA) wants to bring clarity and efficiency to combination product regulation, the agency has announced.

In its proposed new rule, the FDA is amending the classification of products as biological products, devices, drugs or combination products and their assignment to agency components for premarket review and regulation.

The regulator accepts that current advisory content is out-of-date and does not accurately reflect current agency practices and policies.

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