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810.1821 CFR Ch. I (4115 Edition)(b) FDA may terminate a cease distribution and notification order issued under 810.10 or a mandatory recall order issued under 810.13 when the agency determines that

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What is b fda may terminate?

B FDA may terminate is a form that allows the FDA to terminate a biologics license application.

Who is required to file b fda may terminate?

The applicant or holder of a biologics license application is required to file b FDA may terminate.

How to fill out b fda may terminate?

B FDA may terminate can be filled out online through the FDA's electronic submission gateway.

What is the purpose of b fda may terminate?

The purpose of b FDA may terminate is to allow the FDA to terminate a biologics license application if necessary.

What information must be reported on b fda may terminate?

The form must include the reasons for termination and any supporting documentation.

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