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These guidances and information sheets represent the Agency's current guidance on good clinical practice and the conduct of clinical trials. They do not create or confer any rights for or on any person and do not operate to bind FDA or the public. An alternative approach may be used if such approach satisfies the requirements of the applicable statute, regulations, or both. However, in many places throughout these documents, specific regulations are cited and the requirements of the regulations are reiterated. The regulations are enforceable.
Notices contained on this page are those that have been published by the Agency that contain important information about good clinical practices and the conduct of clinical trials.
Information Sheet Guidances represent the agency's current guidance on protection of human subjects of research. Through the FDA Information Sheet Guidance Initiative, information intended to help IRBs, clinical investigators and sponsors fulfill their responsibilities to protect human subjects will be periodically updated. The process of rescinding, revising, and reissuing all of the existing Information Sheets (there are approximately 40) may take several years to complete. The agency plans to make the process as transparent as possible. Therefore, FDA advises users to periodically check this web site for revisions throughout this time period.
The Food and Drug Administration (FDA) is providing notice of a memorandum of understanding (MOU) between FDA and the National Cancer Institute (NCI), part of the National Institutes of Health (NIH) of the Department of Health and Human Services (DHHS). The purpose of this MOU is to establish a formal collaboration between FDA and NCI regarding the creation of a common standards-based data repository to facilitate the electronic exchange and analysis of data from research studies on investigational drugs in a fully secure manner
Federal Register (April 18, 2007, Volume 72, Number 74) [Federal Register in PDF format]
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.
This guidance is intended to provide assistance to the research community in interpreting requirements for submitting reports of unanticipated problems, including certain adverse events reports, to the IRB.
Federal Register Notice | Federal Register Notice in PDF format
This guidance is intended to assist clinical investigators, Institutional Review Boards (IRBs), sponsors, and other interested parties in understanding the FDA's process for handling clinical investigations that include children as subjects and that have been referred to FDA for review under 21 CFR 50.54.
Federal Register (December 22, 2006, Volume 71, pp. 77034-77035) [Federal Register in PDF format]
The guidance entitled "Guidance for Clinical Trial Sponsors: Establishment and Operation of Clinical Trial Data Monitoring Committees" dated March 2006 is intended to assist sponsors of clinical trials in determining when a data monitoring committee (DMC) is needed for study monitoring, and how such committees should operate. The guidance announced in this notice finalizes the draft guidance entitled "Guidance for Clinical Trial Sponsors on the Establishment and Operation of Clinical Trial Data Monitoring Committees" dated November 2001.
Federal Register (March 28, 2006; Volume 71, Number 59) [Federal Register in PDF format]
This guidance clarified the versions 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).
This guidance is intended to provide guidance to industry on the meaning of the term "available therapy" as currently used by the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER) in the FDA in the specific circumstances described in the guidance.
This guidance recommends using a standardized approach for collecting and reporting race and ethnicity information in clinical trials conducted in the United States and abroad for certain FDA regulated products. The recommended standardized approach was developed by the Office of Management and Budget (OMB). The guidance lists the OMB categories for race and ethnicity and describes FDA's reasons for recommending the use of these categories. In addition, this guidance recommends a format for race and ethnicity data within study data that are submitted in standardized data sets such as the Study Data Tabulation Model or in the electronic Common Technical Document (eCTD)."
This guidance provides recommendations to sponsors, contract research organizations, data management centers, clinical investigators and institutional review boards regarding the use of computerized systems in clinical investigations.
Federal Register Notice [Federal Register Notice in PDF format]
The Guidance as a Microsoft Word document.
The Food and Drug Administration (FDA) is announcing the availability of the guidance for industry entitled `"Development and Use of Risk Minimization Action Plans''. The guidance provides guidance to industry on risk management activities for drug products, including biological drug products, in the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER). The guidance addresses the development, implementation, and evaluation of risk minimization action plans for drug products.
(Federal Register (Vol. 70, March 29, 2005, pp.15866-15867) [Federal Register in PDF format]
This guidance describes the preclinical and clinical issues as well as chemistry, manufacturing and controls information that should be considered when planning exploratory studies including studies of related drugs or biologics under an investigational new drug (IND) application.
(Federal Register [PDF])
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.
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.
The Guidance as a Word document.
The Guidance as a Microsoft Word document.
The Food and Drug Administration (FDA) is announcing the availability of the guidance for industry entitled Pharmacovigilance Practices and Pharmacoepidemiologic Assessment.'' This guidance provides guidance to industry on risk management activities for drug products, including biological drug products, in the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER). The guidances addresses good pharmacovigilance practices and pharmacoepidemiologic assessment of observational data.
This guidance addresses issues pertaining to approached to monitoring clinical investigations.
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.)
The Guidance 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."
The Guidance 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).
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.
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.)
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)
Although the primary purpose of this guidance outlines general validation
principles that the FDA consider to be application to the validation of medical
device software or the validation of software used to design, develop, or
manufacture medical devices, it contains useful validation principles that
can be applied to software used in the conduct of clinical trials.
http://www.fda.gov/cdrh/comp/guidance/938.pdf
The Guidance as a Microsoft Word document.
The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled ``Pharmacogenomic Data Submissions.'' The guidance provides recommendations to sponsors holding investigational new drug applications (INDs), new drug applications (NDAs), and biologics license applications (BLAs) on what pharmacogenomic data to submit to the agency during the drug development process, the format of submissions, and how the data will be used in regulatory decision making. The guidance is intended to facilitate scientific progress in the area of pharmacogenomics.
Attachment to Guidance [PDF].
Attachment as a Microsoft Word document
(Federal Register, Vol. 70, March 23, 2005, pp. 14698-14699. Also available as PDF.)
The Guidance as a Microsoft Word document.
The Food and Drug Administration (FDA) is announcing the availability of the guidance for industry entitled "Premarketing Risk Assessment.'' This guidance provides guidance to industry on risk management activities for drug products, including biological drug products, in the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER). The guidances addresses premarket risk assessment.
FDA is announcing the availability of this guidance for industry. This is one in a series of guidance documents on providing regulatory submissions to FDA in electronic format. This guidance discusses issues related to the electronic submission of new drug applications (NDAs), abbreviated new drug applications (ANDAs), biologics license applications (BLAs), investigational new drug applications (INDs), master files, advertising material, and promotional labeling using the electronic common technical document (eCTD) specifications.
Federal Register Notice of Availability
Federal Register Notice in PDF format]
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
[Federal Register Notice in PDF format]
This guidance is intended to assist sponsors, institutions, institutional review boards (IRBs), and clinical investigators involved in multicenter clinical research in meeting the requirements of 21 CFR part 56 by facilitating the use of a centralized IRB review process (use of a single central IRB), especially in situations where centralized review could improve efficiency of IRB review.
Federal Register (March 16, 2006, Volume 71, Number 51)
Pre-publication Notice [PDF]
FDA is issuing this guidance to inform sponsors, institutional review boards (IRBs), clinical investigators, and agency staff that the FDA intends to exercise enforcement discretion, under certain circumstances, with respect to its current regulations governing the requirement for informed consent when human specimens are used for FDA regulated in vitro diagnostic device investigations.
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.
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.
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.
This document in Spanish.
(For help in viewing these documents, contact the HHS
Help Desk.)
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).
The purpose of this document is to offer a systematic approach to quality risk management. It serves as a foundation or resource document that is independent of, yet supports, other ICH Quality documents and complements existing quality practices, requirements, standards, and guidelines within the pharmaceutical industry and regulatory environment. It specifically provides guidance on the principles and some of the tools of quality risk management that can enable more effective and consistent risk-based decisions, by both regulators and industry, regarding the quality of drug substances and drug products across the product lifecycle. It is not intended to create any new expectations beyond the current regulatory requirements.
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