Citations within the context of their regulations
Review the enforcement history for every citation given out with the Multi sector.
21 CFR 312.6(a) - (a) The immediate package of an investigational new drug intended for human use shall bear a labe...
21 CFR 312.8(a)(3) - (3) A sponsor must obtain prior written authorization from FDA to charge for an investigational d...
21 CFR 312.7(a) - (a) Promotion of an investigational new drug. A sponsor or investigator, or any person acting on...
21 CFR 312.7(b) - (b) Commercial distribution of an investigational new drug. A sponsor or investigator shall not ...
21 CFR 312.20(b) - (b) A sponsor shall not begin a clinical investigation subject to § 312.2(a) until the investigat...
21 CFR 312.20(a) - (a) A sponsor shall submit an IND to FDA if the sponsor intends to conduct a clinical investigati...
21 CFR 312.20(c) - (c) A sponsor shall submit a separate IND for any clinical investigation involving an exception f...
21 CFR 312.52(a) - (a) A sponsor may transfer responsibility for any or all of the obligations set forth in this par...
21 CFR 312.53(d) - (d) Selecting monitors. A sponsor shall select a monitor qualified by training and experience to...
21 CFR 312.53(a) - (a) Selecting investigators. A sponsor shall select only investigators qualified by training and...
21 CFR 312.53(b) - (b) Control of drug. A sponsor shall ship investigational new drugs only to investigators partic...
21 CFR 312.53(c)(1) - (1) A signed investigator statement (Form FDA-1572) containing:
21 CFR 312.53(c)(2) - (2) Curriculum vitae. A curriculum vitae or other statement of qualifications of the investigato...
21 CFR 312.53(c)(4) - (4) Financial disclosure information. Sufficient accurate financial information to allow the spo...
21 CFR 312.55(b) - (b) The sponsor shall, as the overall investigation proceeds, keep each participating investigato...
21 CFR 312.55(a) - (a) Before the investigation begins, a sponsor (other than a sponsor-investigator) shall give eac...
21 CFR 312.57(b) - (b) A sponsor shall maintain complete and accurate records showing any financial interest in § 54...
21 CFR 312.57(d) - (d) A sponsor shall retain reserve samples of any test article and reference standard identified ...
21 CFR 312.57(a) - (a) A sponsor shall maintain adequate records showing the receipt, shipment, or other disposition...
21 CFR 312.57(c) - (c) A sponsor shall retain the records and reports required by this part for 2 years after a mark...
21 CFR 312.60 - General responsibilities of investigators.
21 CFR 312.61 - Control of the investigational drug.
21 CFR 312.62(c) - (c) Record retention. An investigator shall retain records required to be maintained under this ...
21 CFR 312.62(a) - (a) Disposition of drug. An investigator is required to maintain adequate records of the disposi...
21 CFR 312.62(b) - (b) Case histories. An investigator is required to prepare and maintain adequate and accurate ca...
21 CFR 312.56(a) - (a) The sponsor shall monitor the progress of all clinical investigations being conducted under i...
21 CFR 312.56(c) - (c) The sponsor shall review and evaluate the evidence relating to the safety and effectiveness o...
21 CFR 312.56(b) - (b) A sponsor who discovers that an investigator is not complying with the signed agreement (Form...
21 CFR 312.59 - Disposition of unused supply of investigational drug.
21 CFR 312.66 - Assurance of IRB review.
21 CFR 312.69 - Handling of controlled substances.
21 CFR 312.58(a) - (a) FDA inspection. A sponsor shall upon request from any properly authorized officer or employe...
21 CFR 312.68 - Inspection of investigator's records and reports.
21 CFR 312.64(a) - (a) Progress reports. The investigator shall furnish all reports to the sponsor of the drug who ...
21 CFR 312.64(d) - (d) Financial disclosure reports. The clinical investigator shall provide the sponsor with suffi...
21 CFR 312.64(b) - (b) Safety reports. An investigator must immediately report to the sponsor any serious adverse e...
21 CFR 312.50 - General responsibilities of sponsors.
21 CFR 312.120(c) - (c) Waivers.
21 CFR 50.20 - General requirements for informed consent.
21 CFR 50.24(a)(1) - (1) The human subjects are in a life-threatening situation, available treatments are unproven or ...
21 CFR 50.24(a)(2) - (2) Obtaining informed consent is not feasible because:
21 CFR 50.24(a)(3) - (3) Participation in the research holds out the prospect of direct benefit to the subjects becaus...
21 CFR 50.24(a)(5) - (5) The proposed investigational plan defines the length of the potential therapeutic window base...
21 CFR 50.24(a)(6) - (6) The IRB has reviewed and approved informed consent procedures and an informed consent documen...
21 CFR 50.24(a)(7) - (7) Additional protections of the rights and welfare of the subjects will be provided, including,...
21 CFR 50.27(a) - (a) Except as provided in § 56.109(c), informed consent shall be documented by the use of a writt...
21 CFR 50.27(b)(1) - (1) A written consent document that embodies the elements of informed consent required by § 50.25...
21 CFR 50.27(b)(2) - (2) A short form written consent document stating that the elements of informed consent required ...
21 CFR 50.25(c) - (c) When seeking informed consent for applicable clinical trials, as defined in 42 U.S.C. 282(j)(...
21 CFR 50.25(a)(1) - (1) A statement that the study involves research, an explanation of the purposes of the research ...
21 CFR 50.25(a)(2) - (2) A description of any reasonably foreseeable risks or discomforts to the subject.
21 CFR 50.25(a)(3) - (3) A description of any benefits to the subject or to others which may reasonably be expected fr...
21 CFR 50.25(a)(4) - (4) A disclosure of appropriate alternative procedures or courses of treatment, if any, that migh...
21 CFR 50.25(a)(5) - (5) A statement describing the extent, if any, to which confidentiality of records identifying th...
21 CFR 50.25(a)(6) - (6) For research involving more than minimal risk, an explanation as to whether any compensation ...
21 CFR 50.25(a)(7) - (7) An explanation of whom to contact for answers to pertinent questions about the research and r...
21 CFR 50.25(a)(8) - (8) A statement that participation is voluntary, that refusal to participate will involve no pena...
21 CFR 50.25(b)(1) - (1) A statement that the particular treatment or procedure may involve risks to the subject (or t...
21 CFR 50.25(b)(2) - (2) Anticipated circumstances under which the subject's participation may be terminated by the in...
21 CFR 50.25(b)(3) - (3) Any additional costs to the subject that may result from participation in the research.
21 CFR 50.25(b)(4) - (4) The consequences of a subject's decision to withdraw from the research and procedures for ord...
21 CFR 50.25(b)(5) - (5) A statement that significant new findings developed during the course of the research which m...
21 CFR 50.25(b)(6) - (6) The approximate number of subjects involved in the study.
21 CFR 50.52 - Clinical investigations involving greater than minimal risk but presenting the prospect of direct...
21 CFR 50.51 - Clinical investigations not involving greater than minimal risk.
21 CFR 50.53 - Clinical investigations involving greater than minimal risk and no prospect of direct benefit to ...
21 CFR 50.55(a) - (a) In addition to the determinations required under other applicable sections of this subpart D,...
21 CFR 50.55(g) - (g) When the IRB determines that assent is required, it must also determine whether and how assen...
21 CFR 50.55(b) - (b) In determining whether children are capable of providing assent, the IRB must take into accou...
21 CFR 50.55(f) - (f) Permission by parents or guardians must be documented in accordance with and to the extent re...
21 CFR 50.55(e)(2) - (2) Where clinical investigations are covered by § 50.53 or § 50.54 and permission is to be obtai...
21 CFR 56.103(a) - (a) Except as provided in §§ 56.104 and 56.105, any clinical investigation which must meet the re...
21 CFR 56.104(c) - (c) Emergency use of a test article, provided that such emergency use is reported to the IRB with...
21 CFR 56.107(d) - (d) Each IRB shall include at least one member who is not otherwise affiliated with the instituti...
21 CFR 56.107(f) - (f) An IRB may, in its discretion, invite individuals with competence in special areas to assist ...
21 CFR 56.107(c) - (c) Each IRB shall include at least one member whose primary concerns are in the scientific area ...
21 CFR 56.107(e) - (e) No IRB may have a member participate in the IRB's initial or continuing review of any project...
21 CFR 56.107(a) - (a) Each IRB shall have at least five members, with varying backgrounds to promote complete and a...
21 CFR 56.106(c) - (c) When must an IRB register? Each IRB must submit an initial registration. The initial registr...
21 CFR 56.106(a) - (a) Who must register? Each IRB in the United States that reviews clinical investigations regula...
21 CFR 56.106(e) - (e) How does an IRB revise its registration information? If an IRB's contact or chair person inf...
21 CFR 56.106(b)(1) - (1) The name, mailing address, and street address (if different from the mailing address) of the ...
21 CFR 56.106(b)(2) - (2) The IRB's name, mailing address, street address (if different from the mailing address), phon...
21 CFR 56.106(b)(3) - (3) The approximate number of active protocols involving FDA-regulated products reviewed. For pur...
21 CFR 56.106(b)(4) - (4) A description of the types of FDA-regulated products (such as biological products, color addi...
21 CFR 56.113 - Suspension or termination of IRB approval of research.
21 CFR 56.112 - Review by institution.
21 CFR 56.110(c) - (c) Each IRB which uses an expedited review procedure shall adopt a method for keeping all member...
21 CFR 56.110(b) - (b) An IRB may use the expedited review procedure to review either or both of the following:
21 CFR 56.110(b)(1) - (1) Some or all of the research appearing on the list and found by the reviewer(s) to involve no ...
21 CFR 56.110(b)(2) - (2) minor changes in previously approved research during the period (of 1 year or less) for which...
21 CFR 56.109(a) - (a) An IRB shall review and have authority to approve, require modifications in (to secure approv...
21 CFR 56.109(f) - (f) An IRB shall conduct continuing review of research covered by these regulations at intervals ...
21 CFR 56.109(e) - (e) An IRB shall notify investigators and the institution in writing of its decision to approve o...
21 CFR 56.109(b) - (b) An IRB shall require that information given to subjects as part of informed consent is in acc...
21 CFR 56.109(h) - (h) When some or all of the subjects in a study are children, an IRB must determine that the rese...
21 CFR 56.109(c)(1) - (1) The IRB may, for some or all subjects, waive the requirement that the subject, or the subject...
21 CFR 56.109(c)(2) - (2) The IRB may, for some or all subjects, find that the requirements in § 50.24 of this chapter ...
21 CFR 56.111(c) - (c) In order to approve research in which some or all of the subjects are children, an IRB must d...
21 CFR 56.111(b) - (b) When some or all of the subjects, such as children, prisoners, pregnant women, handicapped, o...
21 CFR 56.111(a)(1) - (1) Risks to subjects are minimized:
21 CFR 56.111(a)(3) - (3) Selection of subjects is equitable. In making this assessment the IRB should take into accoun...
21 CFR 56.111(a)(4) - (4) Informed consent will be sought from each prospective subject or the subject's legally author...
21 CFR 56.111(a)(5) - (5) Informed consent will be appropriately documented, in accordance with and to the extent requi...
21 CFR 56.111(a)(6) - (6) Where appropriate, the research plan makes adequate provision for monitoring the data collect...
21 CFR 56.108(c) - (c) Except when an expedited review procedure is used (see § 56.110), review proposed research at...
21 CFR 56.108(b)(1) - (1) Any unanticipated problems involving risks to human subjects or others;
21 CFR 56.108(b)(2) - (2) any instance of serious or continuing noncompliance with these regulations or the requirement...
21 CFR 56.108(b)(3) - (3) any suspension or termination of IRB approval.
21 CFR 56.108(a)(1) - (1) For conducting its initial and continuing review of research and for reporting its findings a...
21 CFR 56.108(a)(2) - (2) for determining which projects require review more often than annually and which projects nee...
21 CFR 56.108(a)(3) - (3) for ensuring prompt reporting to the IRB of changes in research activity; and
21 CFR 56.108(a)(4) - (4) for ensuring that changes in approved research, during the period for which IRB approval has ...
21 CFR 56.115(b) - (b) The records required by this regulation shall be retained for at least 3 years after completi...
21 CFR 56.115(a)(1) - (1) Copies of all research proposals reviewed, scientific evaluations, if any, that accompany the...
21 CFR 56.115(a)(2) - (2) Minutes of IRB meetings which shall be in sufficient detail to show attendance at the meeting...
21 CFR 56.115(a)(3) - (3) Records of continuing review activities.
21 CFR 56.115(a)(4) - (4) Copies of all correspondence between the IRB and the investigators.
21 CFR 56.115(a)(5) - (5) A list of IRB members identified by name; earned degrees; representative capacity; indication...
21 CFR 56.115(a)(6) - (6) Written procedures for the IRB as required by § 56.108 (a) and (b).
21 CFR 56.115(a)(7) - (7) Statements of significant new findings provided to subjects, as required by § 50.25.
21 CFR 58.10 - Applicability to studies performed under grants and contracts.
21 CFR 58.35(b)(5) - (5) Determine that no deviations from approved protocols or standard operating procedures were ma...
21 CFR 58.33(c) - (c) Unforeseen circumstances that may affect the quality and integrity of the nonclinical laborat...
21 CFR 58.63(b) - (b) The written standard operating procedures required under § 58.81(b)(11) shall set forth in su...
21 CFR 58.81(c) - (c) Each laboratory area shall have immediately available laboratory manuals and standard operati...
21 CFR 58.105(a) - (a) The identity, strength, purity, and composition or other characteristics which will appropria...
21 CFR 58.120(a)(11) - (11) The date of approval of the protocol by the sponsor and the dated signature of the study dir...
21 CFR 58.120(a)(3) - (3) The name of the sponsor and the name and address of the testing facility at which the study i...
21 CFR 58.120(a)(6) - (6) A description of the experimental design, including the methods for the control of bias.
21 CFR 58.130(e) - (e) All data generated during the conduct of a nonclinical laboratory study, except those that ar...
21 CFR 58.130(a) - (a) The nonclinical laboratory study shall be conducted in accordance with the protocol.
21 CFR 58.185(b) - (b) The final report shall be signed and dated by the study director.
21 CFR 58.185(a)(1) - (1) Name and address of the facility performing the study and the dates on which the study was in...
21 CFR 58.185(a)(6) - (6) A description of the methods used.
21 CFR 58.190(a) - (a) All raw data, documentation, protocols, final reports, and specimens (except those specimens ...
21 CFR 58.195(e) - (e) Summaries of training and experience and job descriptions required to be maintained by § 58.2...
21 CFR 58.195(g) - (g) Records required by this part may be retained either as original records or as true copies su...