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Biologic-device combination product

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Reference no: EM133463423

Research and post two specific examples of a combination product and describe:

Whether it is a drug-biologic, drug-device, or biologic-device combination product,

Which office is responsible for its review at FDA and why

What its primary mode of action is,

What cGMP might be used and why, and

Review the postmarketing guidance posted in Canvas and explain what postmarketing requirements there may be.

Reference no: EM133463423

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