The FDA On Combination Products (drug-biologic with medical device)

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Updated June 30, 2021

The original link broke.

You can read more about the topic here:

Frequently Asked Questions About Combination Products - FDA.gov

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It's hard enough to comply with a single set of regulations. Now it's even harder, if you manufacture a combination product (which has a drug/biologic component and a medical device component). That's because a larger set of rules and regulations have to be followed, says this PharmTech Talk article, "Combo Products Come with More Regs." 

Bottomline, you can expect an increase in "GMP regulatory action along both the laboratory and manufacturing lines." 

Previous Posts: 

Nice Review of US FDA Medical Device Regulation 

Medical Devices Containing Antimicrobial Agents - FDA Guidance Pending 

FDA Guidance Documents - FDA Current Thinking (free) 

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