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U.S. Department of Health and Human Services

For Industry

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Where can I find industry guidances applicable to human drug products? How can I easily retrieve newly added guidances?

Guidance documents represent the Agency's current thinking on a particular subject. They do not create or confer any rights for or on any person and do not operate to bind FDA or the public. An alternative approach may be used if such approach satisfies the requirements of the applicable statute, regulations, or both.

Relevant Resources:

Guidances

Newly Added Guidances

Spanish Language Guidances

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