0338 21cfr601 35 2007

Food and Drug Administration, HHS

§ 601.40

in diagnostic or therapeutic patient
management.
(5) For a claim that does not fall
within the indication categories identified in § 601.33, the applicant or sponsor
should consult FDA on how to establish the effectiveness of the diagnostic
radiopharmaceutical for the claim.
(b) The accuracy and usefulness of
the diagnostic information is determined by comparison with a reliable
assessment of actual clinical status. A
reliable assessment of actual clinical
status may be provided by a diagnostic
standard or standards of demonstrated
accuracy. In the absence of such diagnostic standard(s), the actual clinical
status must be established in another
manner, e.g., patient followup.
§ 601.35

may require, among other information,
the following types of data:
(A) Pharmacology data,
(B) Toxicology data,
(C) Clinical adverse event data, and
(D) Radiation safety assessment.
(2) The amount of new safety data required will depend on the characteristics of the product and available information regarding the safety of the diagnostic radiopharmaceutical, and its
carrier or ligand, obtained from other
studies and uses. Such information
may include, but is not limited to, the
dose, route of administration, frequency of use, half-life of the ligand or
carrier, half-life of the radionuclide,
and results of clinical and preclinical
studies. FDA will establish categories
of diagnostic radiopharmaceuticals
based on defined characteristics relevant to risk and will specify the
amount and type of safety data that
are appropriate for each category (e.g.,
required safety data may be limited for
diagnostic radiopharmaceuticals with
a well established, low-risk profile).
Upon reviewing the relevant product
characteristics and safety information,
FDA will place each diagnostic radiopharmaceutical into the appropriate
safety risk category.
(d) Radiation safety assessment. The
radiation safety assessment must establish the radiation dose of a diagnostic radiopharmaceutical by radiation dosimetry evaluations in humans
and appropriate animal models. The
maximum tolerated dose need not be
established.

Evaluation of safety.

(a) Factors considered in the safety
assessment of a diagnostic radiopharmaceutical include, among others,
the following:
(1) The radiation dose;
(2) The pharmacology and toxicology
of the radiopharmaceutical, including
any radionuclide, carrier, or ligand;
(3) The risks of an incorrect diagnostic determination;
(4) The adverse reaction profile of the
drug;
(5) Results of human experience with
the radiopharmaceutical for other uses;
and
(6) Results of any previous human experience with the carrier or ligand of
the radiopharmaceutical when the
same chemical entity as the carrier or
ligand has been used in a previously
studied product.
(b) The assessment of the adverse reaction profile includes, but is not limited to, an evaluation of the potential
of the diagnostic radiopharmaceutical,
including the carrier or ligand, to elicit the following:
(1) Allergic or hypersensitivity responses,
(2) Immunologic responses,
(3) Changes in the physiologic or biochemical function of the target and
nontarget tissues, and
(4) Clinically detectable signs or
symptoms.
(c)(1) To establish the safety of a diagnostic radiopharmaceutical, FDA

Subpart E—Accelerated Approval
of Biological Products for Serious or Life-Threatening Illnesses
SOURCE: 57 FR 58959, Dec. 11, 1992, unless
otherwise noted.

§ 601.40

Scope.

This subpart applies to certain biological products that have been studied
for their safety and effectiveness in
treating serious or life-threatening illnesses and that provide meaningful
therapeutic benefit to patients over existing treatments (e.g., ability to treat
patients unresponsive to, or intolerant

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