Title 21

SECTION 516.25

516.25 Refusal to grant MUMS-drug designation.

§ 516.25 Refusal to grant MUMS-drug designation.

(a) FDA will refuse to grant a request for MUMS-drug designation if any of the following reasons apply:

(1) The drug is not intended for use in a minor species or FDA determines that there is insufficient evidence to demonstrate that the drug is intended for a minor use in a major species.

(2) The drug is the same drug in the same dosage form for the same intended use as one that already has a MUMS-drug designation but has not yet been conditionally approved or approved.

(3) The drug is the same drug in the same dosage form for the same intended use as one that is already conditionally approved or approved. A drug that FDA has found to be functionally superior is not considered the same drug as an already conditionally approved or approved drug even if it is otherwise the same drug in the same dosage form for the same intended use.

(4) The sponsor has failed to provide:

(i) A credible scientific rationale in support of the intended use,

(ii) Sufficient information about the product development plan for the drug, its dosage form, and its intended use to establish that adherence to the plan can lead to successful drug development in a timely manner, and

(iii) Any other information required under § 516.20.

(b) FDA may refuse to grant a request for MUMS-drug designation if the request for designation contains an untrue statement of material fact or omits material information.

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