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What is the classification of FDA?

The Food and Drug Administration’s approval of Aduhelm in June has drawn ... is considering the possibility of coverage of not only Aduhelm, but also this entire new class of Alzheimer’s disease therapies. We hope our actions today will facilitate ...

What is FDA guidance for industry?

These documents usually discuss more specific products or issues that relate to the design, production, labeling, promotion, manufacturing, and testing of regulated products. Guidance documents may also relate to the processing, content, and evaluation or approval of submissions as well as to inspection and enforcement policies.

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