CDER pediatric use supplement

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					                                     DEPARTMENT OF HEALTH AND HUMAN SERVICES
                                                PUBLIC HEALTH SERVICE
                                             FOOD AND DRUG ADMINISTRATION

                                     CDER PEDIATRIC USE SUPPLEMENT
 NDA / NUMBER:                           SUPPLEMENT / NUMBER:                   LETTER DATE:

 (See back of form for complete definitions.)

                 (ii)                                 (v)                                      (vii)

                 (iii)                                (vi)                                     (viii)



                 Raw data / Study Analyses


                 Raw data / Study Analyses


             Clinical Efficacy Trials:                              Anecdotal Reports:

                 Raw data / Study Analyses                              MedWatch / Form 3500

                 Literature                                             Literature


 PROJECT MANAGER:                                                               DATE:


FORM FDA 3437 (06/95)                                                                                   PSC Media Arts (301) 443-1090   EF
                                                        21 CFR 201.57 (f) (9)
   (ii)   If there is a specific pediatric in-    similar in the pediatric and adult             ment have not been met for a particular
   dication (i.e., an indication different from   populations to permit extrapolation from       pediatric population, the "Pediatric use"
   those approved for adults) that is sup-        the adult efficacy data to pediatric           subsection of the labeling shall contain
   ported by adequate and well controlled         patients. The additional information sup-      an appropriate statement such as
   studies in the pediatric population, it        porting pediatric use must ordinarily          "Safety and effectiveness in pediatric
   shall be described under the "Indi-            include data on the pharmacokinetics           patients below the age of (-) have not
   cations and Usage" section of the              of the drug in the pediatric population        been established." If use of the drug in
   labeling, and appropriate pediatric do-        for determination of appropriate dosage.       this pediatric population is associated
   sage information shall be given under          Other information, such as data from           with a specific hazard, the hazard shall
   the "Dosage and Administration" section        pharmacodynamic studies of the drug in         be described in this subsection of the
   of the labeling. The "Pediatric use"           the pediatric population, data from other      labeling, or if appropriate, the hazard
   subsection shall cite any limitations on       studies supporting the safety or effec-        shall be stated in the "Contra-
   the pediatric indication, need for specific    tiveness of the drug in pediatric              indications" or "Warnings" section of the
   monitoring, specific hazards associated        patients, pertinent premarketing or post-      labeling and this subsection shall refer
   with use of the drug in any subsets of         marketing studies or experience, may           to it.
   the pediatric population (e.g., neo-           be necessary to show that the drug can
   nates), differences between pediatric          be used safely and effectively in              (vi) If the requirements for a finding of
   and adult responses to the drug, and           pediatric patients. When a drug is             substantial evidence to support a pedi-
   other information related to the safe and      approved for pediatric use based on            atric indication or a pediatric use state-
   effective pediatric use of the drug. Data      adequate and well-controlled studies in        ment have not been met for any pedi-
   summarized in this subsection of the           adults with other information supporting       atric population, this subsection of the
   labeling should be discussed in more           pediatric use, the "Pediatric use"             labeling shall contain the following
   detail, if appropriate, under the "Clinical    subsection of the labeling shall contain       statement: "Safety and effectiveness in
   Pharmacology" or "Clinical Studies"            either the following statement, or a           pediatric patients have not been estab-
   section. As appropriate, this information      reasonable alternative: "The safety and        lished." If use of the drug in premature
   shall also be contained in the "Contrain-      effectiveness of (drug name) have been         or neonatal infants, or other pediatric
   dications," "Warnings," and elsewhere          established in the age groups -- to --         subgroups, is associated with a specific
   in the "Precautions" sections.                 (note any limitations, e.g., no data for       hazard, the hazard shall be described in
                                                  pediatric patients under 2, or only            this subsection of the labeling, or, if
   (iii) If there are specific statements on      applicable to certain indications ap-          appropriate, the hazard shall be stated
   pediatric use of the drug for an indi-         proved in adults). Use of (drug name) in       in the "Contraindications" or "Warning"
   cation also approved for adults that are       these age groups is supported by               section of the labeling and this sub-
   based on adequate and well controlled          evidence from adequate and well-               section shall refer to it.
   studies in the pediatric population, they      controlled studies of (drug name) in
   shall be summarized in the "Pediatric          adults with additional data (insert            (vii) If the sponsor believes that none
   use" subsection of the labeling and            wording that accurately describes the          of the statements described in para-
   discussed in more detail, if appropriate,      data submitted to support a finding of         graphs (f)(9)(ii) through (f)(9)(vi) of this
   under the "Clinical Pharmacology" and          substantial evidence of effectiveness in       section is appropriate or relevant to the
   "Clinical Studies" sections. Appropriate       the pediatric population)." Data sum-          labeling of a particular drug, the sponsor
   pediatric dosage shall be given under          marized in the preceding prescribed            shall provide reasons for omission of
   the "Dosage and Administration" section        statement in this subsection of the            the statements and may propose alter-
   of the labeling. The "Pediatric use"           labeling shall be discussed in more            native statement(s). FDA may permit
   subsection of the labeling shall also cite     detail, if appropriate, under the "Clinical    use of an alternative statement if FDA
   any limitations on the pediatric use           Pharmacology" or the "Clinical Studies"        determines that no statement described
   statement, need for specific monitoring,       section. For example, pediatric pharma-        in those paragraphs is appropriate or
   specific hazards associated with use of        cokinetic or pharmacodynamic studies           relevant to the drug’s labeling and that
   the drug in any subsets of the pediatric       and dose-response information should           the alternative statement is accurate
   population (e.g., neonates), differences       be described in the "Clinical Pharma-          and appropriate.
   between pediatric and adult responses          cology" section. Pediatric dosing in-
   to the drug, and other information rela-       structions shall be included in the            (viii) If the drug product contains one
   ted to the safe and effective pediatric        "Dosage and Administration" section of         or more inactive ingredients that present
   use of the drug. As appropriate, this          the labeling. Any differences between          an increased risk of toxic effects to
   information shall also be contained in         pediatric and adult responses, need for        neonates or other pediatric subgroups,
   the "Contraindications," "Warnings," and       specific monitoring, dosing adjustments,       a special note of this risk shall be made,
   elsewhere in the "Precautions" sections.       and any other information related to           generally in the "Contraindications",
                                                  safe and effective use of the drug in          "Warnings," or "Precautions" sections.
   (iv)   FDA may approve a drug for              pediatric patients shall be cited briefly in
   pediatric use based on adequate and            the "Pediatric use" sub-section and, as
   well controlled studies in adults, with        appropriate, in the "Contraindications,"
   other information supporting pediatric         "Warnings," "Precautions," and "Dosage
   use. In such cases, the agency will have       and Administration" sections.
   concluded that the course of the dis-          (v) If the requirements for a finding of
   ease and the effects of the drug, both         substantial evidence to support a pedi-
   beneficial and adverse, are sufficiently       atric indication or a pediatric use state-

FORM FDA 3437 (06/95)

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