action letter

A letter or official communication from the FDA to a new drug application (NDA) drug or medical device sponsor indicating their decision on an application for new drug approval.

Action Letter

A letter or official communication from the US Food & Drug Administration (FDA) to a new drug application (NDA) drug or medical device sponsor indicating their decision on an application.

action letter

A formal ruling issued by the U.S. Food and Drug Administration regarding the status of a therapeutic agent.

单词	action letter
释义	action letter action letter A letter or official communication from the FDA to a new drug application (NDA) drug or medical device sponsor indicating their decision on an application for new drug approval. Action Letter A letter or official communication from the US Food & Drug Administration (FDA) to a new drug application (NDA) drug or medical device sponsor indicating their decision on an application. action letter A formal ruling issued by the U.S. Food and Drug Administration regarding the status of a therapeutic agent.
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