IND Exemptions for Studies of Lawfully
Marketed Drug or Biologicial Products for the Treatment of Cancer 
(188 KB)
The Guidance is also available as a Microsoft Word document.
This guidance is intended to assist sponsors in deciding whether a study of marketed drugs or biological products for treating cancer falls within the exemption under § 312.2(b)(1) (21 CFR 312.2(b)(1)) from the general requirement to submit an investigational new drug application (IND).
FDA Information Sheets for Institutional Review Boards and Clinical Investigators
Information Sheets represent the agency's current guidance on protection of human subjects of research. This 1998 guidance document represents an update of the October 1995 revision of the Information Sheets.
ICH E6: Good Clinical Practice: Consolidated
Guidance
(261 KB)
Good Clinical Practice (GCP) is an international ethical and scientific quality
standard for designing, conducting, recording, and reporting trials that involve
human subjects. Compliance with GCP assures that the rights, safety, and well-being
of trial subjects are protected and that the clinical trial data are credible.
This International Conference on Harmonization (ICH) guidance provides a unified
standard for the European Union, Japan, and the United States to facilitate
the mutual acceptance of clinical data by the regulatory authorities in those
jurisdictions.
(Federal Register Vol.62, No.90, May 9, 1997, pp. 25691-25709)
This document is also available
in Spanish.
(For help in viewing these documents, contact the HHS
Help Desk.)
ICH E3: Guideline for Industry Structure
and Content of Clinical Study Reports
(240 KB)
This International Conference on Harmonization (ICH) document makes recommendations on information that should be included in a core clinical study report of an individual study of any therapeutic, prophylactic, or diagnostic agent conducted in human subjects. The guideline is intended to assist sponsors in the development of a report that is complete, free from ambiguity, well organized and easy to review.
ICH E5: Ethnic Factors in the Acceptability of Foreign Clinical Data
This International Conference on Harmonization (ICH) document makes recommendations
for strategies to permit clinical data collected in one region to be used to
support drug and biologic registrations in another region while allowing for
the influence of ethnic factors.
(Federal Register Vol.63, No.111, June 10, 1998, p. 31790)
ICH E10: Choice of Control Group and Related Issues in Clinical Trials
This International Conference on Harmonization (ICH) guidance addresses the
choice of control group in clinical trials, discussing five principal types
of controls, two important purposes of clinical trials, and the issue of whether
a trial could have detected a difference between treatments when there was
a difference (assay sensitivity).
(Federal Register, Vol. 66, No. 93, May 14, 2001, pp. 24390-24391)
Guidance
for Industry and Clinical Investigators on the Use of Clinical Holds Following
Clinical Investigator Misconduct
This guidance for industry and clinical investigators provides information
on one by FDA's of its authority to impose a clinical hold on a study or study
site if FDA finds that human subjects are or would be exposed to unreasonable
and significant risk of illness or injury.
Federal Register
Notice of Availability
[Also available in PDF format]
Financial Relationships and Interests in Research Involving Human Subjects: Guidance for Human Subject Protection
HHS Secretary Tommy G. Thompson today released new guidance for protecting research subjects from possible harm caused by financial conflicts of interest in research studies. The guidance document entitled "Financial Relationships and Interests in Research Involving Human Subjects: Guidance for Human Subject Protection," is for Institutional Review Boards (IRBs), investigators, research institutions, and other interested parties as announced in Federal Register, Vol. 69, No.92, May 12, 2004, Page 26393. It applies to all human subjects research conducted or supported by HHS agencies or regulated by the Food and Drug Administration.
Guidance
for Industry on Part 11, Electronic Records; Electronic Signatures--Scope and
Application
This guidance is intended to describe the FDA's current thinking regarding the
scope and application of part 11 of Title 21 of the Code of Federal Regulations;
Electronic Records; Electronic Signatures (21 CFR Part 11).
(For help in viewing this document, contact the HHS
Help Desk.)
(Federal
Register, Vol. 68, Sept. 5, 2003, pp. 52779-52781)
Guidance
for Industry IRB Review of Stand-Alone HIPAA Authorizations Under FDA Regulations
This guidance provides clarification for IRBs of their responsibilities for
reviewing and approving stand-alone authorizations under the HIPAA Privacy Rule.
(For help in viewing this document, contact the HHS
Help Desk.)
(Additional HIPAA guidances can be found on the Department
of Health and Human Service's (DHHS) Office of Civil Rights (OCR) website.)
Guidance for Industry: Guideline for the Monitoring of Clinical Investigators
This guidance addresses issues pertaining to approached to monitoring clinical investigations.
Guidance for Industry: Acceptance of Foreign Clinical Studies
This guidance clarified the verisions of the Declaration of Helsinki that applies to FDA's acceptance of a foreign clinical study not conducted under an investigational new drug application (IND).
Guidance for Industry: Information Program
on Clinical Trials for Serious or Life-Threatening Diseases and Conditions
[46k PDF]
Text version of draft guidance
This guidance is intended to assist sponsors who will be submitting information to the Clinical Trials Data Bank. It addresses statutory and procedural issues for submitting information to the data bank.
Guidance for Industry: Guideline for
the Study and Evaluation of Gender Differences in the Clinical Evaluation of
Drugs[1.83
MB PDF]
This guideline presents guidance on FDA's expectations regarding inclusion of
both genders in drug development.
(For help in viewing this document, contact the HHS Help Desk.)
Computerized Systems Used
in Clinical Trials
(Printer-friendly 46K PDF version)
This guidance addresses issues pertaining to computerized systems used to created, modify, maintain, archive, retrieve, or transmit clinical data intended for submission to FDA. The guidance is being revised and a draft guidance document with the same title is not available.
Guidance for Industry Food-Effect Bioavailability and Fed Bioequivalence Studies
This guidance provides recommendations to sponsors and/or applicants planning to conduct food-effect bioavailability (BA) and fed bioequivalence (BE) studies for orally administered drug products as part of investigational new drug applications (INDs), new drug applications (NDAs) and abbreviated new drug applications (ANDAs), and supplemental applications. (Guidance can be found on this site in PDF format and as a Word document.)
Guidance for Industry: Financial Disclosure by Clinical Investigators
This guidance addresses questions received by FDA concerning the implementation of the final rule on financial disclosure (21 CFR 54). The financial disclosure regulations were intended to ensure that financial interests and arrangements of clinical investigators that could affect the reliability of data submitted to FDA were identified and disclosed to FDA by the applicant.
Guidance for Industry
on Handling and Retention of Bioavailability and Bioequivalence Testing Samples;
Availability [166KB
PDF]
The Guidance is also available as a Microsoft Word document.
Pre-Pub version [23KB
PDF]
Inspection of clinical and analytical sites that perform bioavailability (BA) and bioequivalence (BE) studies frequently reveals the absence of reserve samples at the testing facilities where the studies are conducted. The guidance is intended to clarify how to distribute test articles and reference standards to testing facilities, how to randomly select reserve samples, and how to retain reserve samples."