Warning Letters
Review Warning Letters by infraction
Regulations
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 312.7 - Promotion of investigational drugs.
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 312.52 - Transfer of obligations to a contract research organization.
21 CFR 312.57(a) - (a) A sponsor shall maintain adequate records showing the receipt, shipment, or other disposition...
21 CFR 312.60 - General responsibilities of investigators.
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 312.62 - Investigator recordkeeping and record retention.
21 CFR 312.69 - Handling of controlled substances.
21 CFR 312.50 - General responsibilities of sponsors.
21 CFR 312.66 - Assurance of IRB review.
21 CFR 50.20 - General requirements for informed consent.
21 CFR 50.24 - Exception from informed consent requirements for emergency research.
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 - Documentation of informed consent.
21 CFR 50.27(b)(1) - (1) A written consent document that embodies the elements of informed consent required by § 50.25...
21 CFR 50.25(c) - (c) When seeking informed consent for applicable clinical trials, as defined in 42 U.S.C. 282(j)(...
21 CFR 50.25 - Elements of informed consent.
21 CFR 50.25(a)(2) - (2) A description of any reasonably foreseeable risks or discomforts to the subject.
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(b)(3) - (3) Any additional costs to the subject that may result from participation in the research.
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 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(a) - (a) Each IRB shall have at least five members, with varying backgrounds to promote complete and a...
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(f) - (f) An IRB may, in its discretion, invite individuals with competence in special areas to assist ...
21 CFR 56.107 - IRB membership.
21 CFR 56.113 - Suspension or termination of IRB approval of research.
21 CFR 56.110(b) - (b) An IRB may use the expedited review procedure to review either or both of the following:
21 CFR 56.109(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(c) - (c) An IRB shall require documentation of informed consent in accordance with § 50.27 of this cha...
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 56.111(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 - Criteria for IRB approval of research.
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) - (b) Follow written procedures for ensuring prompt reporting to the IRB, appropriate institutional...
21 CFR 56.108 - IRB functions and operations.
21 CFR 56.108(a) - (a) Follow written procedures:
21 CFR 56.108(a)(1) - (1) For conducting its initial and continuing review of research and for reporting its findings a...
21 CFR 56.115(b) - (b) The records required by this regulation shall be retained for at least 3 years after completi...
21 CFR 56.115 - IRB records.
21 CFR 56.115(a) - (a) An institution, or where appropriate an IRB, shall prepare and maintain adequate documentatio...
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)(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 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 58.130(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 58.190(a) - (a) All raw data, documentation, protocols, final reports, and specimens (except those specimens ...