Science & Research
Proposed Regulations and Draft Guidances
Draft regulations and guidances are documents that have been proposed, but FDA has not made a decision as to whether the proposal will be adopted in whole, in part, or not at all. Each FDA draft document lists how to submit comments to the agency concerning the draft.
The entries below are listed in reverse chronological order by publication date.
6/12/2012: Guidance for IRBs, Clinical Investigators and Sponsors - Considerations When Transferring Clinical Investigation Oversight to Another IRB
This guidance discusses the regulatory responsibilities of institutional review boards (IRBs), clinical investigators, and sponsors when oversight of a previously approved clinical investigation under FDA’s jurisdiction is transferred from one IRB to another IRB. This guidance also addresses questions that have been previously raised concerning procedures and processes that are required and/or recommended by FDA when such oversight is transferred. FDA encourages individuals to contact the agency directly to discuss any unusual circumstances.
To enhance human subject protections and reduce regulatory burden, FDA and the Office for Human Research Protections (OHRP) have been actively working to harmonize the agencies' regulatory requirements and guidance for human subjects research. This guidance document was developed as a part of these efforts. For studies subject to 45 CFR part 46 (i.e., studies that are funded, conducted, or supported by the Department of Health and Human Services), OHRP has also issued draft guidance entitled, "Considerations in Transferring a Previously Approved Research Project to a New IRB or Research Institution."
Comments are Due by August 13, 2012.
9/7/2011: Guidance on Exculpatory Language in Informed Consent
This draft guidance has been prepared jointly by the Office for Human Research Protections (OHRP) and the Food and Drug Administration (FDA). This document applies to non-exempt human subject research conducted or supported by the Department of Health and Human Services (HHS) and is intended for clinical investigators, institutional review boards, and funding agencies that may be responsible for review or oversight of human subject research conducted or supported by HHS. This document also applies to human subject research regulated by FDA and is intended for clinical investigators, sponsors, and institutional review boards conducting or reviewing such research.
This document provides guidance on the regulatory prohibition on the inclusion of exculpatory language in informed consent. The document includes examples of language that OHRP and FDA consider acceptable as well as examples of language that the agencies would consider exculpatory. When finalized, this document will supersede OHRP’s November 15, 1996, guidance entitled, “‘Exculpatory Language’ in Informed Consent” and question number 52 in FDA’s January 1998 guidance entitled, “Institutional Review Boards Frequently Asked Questions – Information Sheet Guidance for Institutional Review Boards and Clinical Investigators.”
Comments are due by November 7, 2011.
8/28/2011: Draft Guidance for Industry - Oversight of Clinical Investigations: A Risk-Based Approach to Monitoring
FDA is publishing this new draft guidance to assist sponsors of clinical investigations in developing risk-based monitoring strategies and plans for clinical investigations of human drug and biological products, medical devices, and combinations thereof. This guidance is intended to make clear that sponsors can use a variety of approaches to meet their monitoring responsibilities during clinical investigations. This guidance describes a modern, risk-based approach to monitoring that focuses on critical study parameters and relies on a combination of monitoring activities to effectively oversee a study.
Comments are due by November 28, 2011
8/15/2011: Draft Guidance for Industry, Clinical Investigators, and Food and Drug Administration Staff - Design Considerations for Pivotal Clinical Investigations for Medical Devices
This document is intended to provide guidance to those involved in designing clinical studies intended to support premarket submissions for medical devices and FDA staff who review those submissions.
Comments are due by November 14, 2011
7/26/2011 - Advanced Notice of Proposed Rule Making - Human Subjects Research Protections: Enhancing Protections for Research Subjects and Reducing Burden, Delay, and Ambiguity for Investigators - The Office of the Secretary of the Department of Health and Human Services (HHS) in coordination with the Office of Science and Technology Policy (OSTP) is issuing this advance notice of proposed rulemaking (ANPRM) to request comment on how current regulations for protecting human subjects who participate in research might be modernized and revised to be more effective. This ANPRM seeks comment on how to better protect human subjects who are involved in research, while facilitating valuable research and reducing burden, delay, and ambiguity for investigators.
The comment period for the proposed rule published July 26, 2011, at 76 FR 44512 is extended. Comments will be received through October 26, 2011.
7/14/2011: Draft Guidance for Industry and Food and Drug Administration Staff - In Vitro Companion Diagnostic Devices
This draft guidance is intended to assist (1) sponsors who are planning to develop a therapeutic product that depends on the use of an in vitro companion diagnostic device (or test) for its safe and effective use and (2) sponsors planning to develop an in vitro companion diagnostic device that is intended to be used with a corresponding therapeutic product.
Comments are due by September 12, 2011
8/15/2011: Draft Guidance for Industry and Food and Drug Administration Staff - Factors to Consider when Making Benefit-Risk Determinations in Medical Device Premarket Review
FDA has developed this draft guidance document to provide greater clarity for FDA reviewers and industry regarding the factors FDA considers when making benefit-risk determinations during the premarket review process for certain medical devices.
Comments are due by November 14, 2011
6/1/2011: Commercially Distributed In Vitro Diagnostic Products Labeled for Research Use Only or Investigational Use Only: Frequently Asked Questions, Draft Guidance for Industry and FDA Staff
This draft guidance document is intended to clarify the types of in vitro diagnostic (IVD) products that are properly labeled “for research use only” ("RUO") or “for investigational use only” ("IUO"), and provide the responses of the Center for Devices and Radiological Health (CDRH) and the Center for Biologics Evaluation and Research (CBER) to some frequently asked questions about how such products should and should not be marketed. This document is intended for manufacturers and distributors of RUO and IUO IVD products and any other entities who label IVD products.
Comments are due by August 30, 2011
5/24/2011: Financial Disclosure by Clinical Investigators, Guidance for Clinical Investigators, Industry, and FDA Staff (PDF - 151KB)
This guidance is intended to assist clinical investigators, industry, and FDA staff in interpreting and complying with the regulations governing financial disclosure by clinical investigators, 21 CFR part 54. This document is a revision of the Guidance for Industry: Financial Disclosure by Clinical Investigators dated March 20, 2001. The revised guidance addresses issues raised by the Office of the Inspector General (OIG), Department of Health and Human Services, in its report, OEI-05-07-00730, The Food and Drug Administration’s Oversight of Clinical Investigators’ Financial Information as well as questions FDA has received from industry and the public.
Comments are due by July 25, 2011
1/7/2011: Electronic Source Documentation in Clinical Investigations, Guidance for Industry (Draft) (PDF - 170KB)
This document provides guidance to sponsors, contract research organizations (CROs), data management centers, and clinical investigators on capturing, using, and archiving electronic data in FDA-regulated clinical investigations. This guidance is intended to ensure the reliability, quality, integrity, and traceability of electronic source data and source records maintained at the site for FDA inspection.
Comments are due April 7, 2011
10/14/2010: Investigational New Drug Applications (INDs) - Determining Whether Human Research Studies Can Be Conducted Without an IND (PDF - 210KB)
This guidance is intended to assist clinical investigators, sponsors, and sponsor-investigators in determining whether human research studies must be conducted under an investigational new drug application (IND), as described in Title 21 of the Code of Federal Regulations, part 312 (21 CFR part 312) (the IND regulations). This guidance describes when an IND is required, specific situations in which an IND is not required, and a range of issues that, in FDA’s experience, have been the source of confusion or misperceptions about the application of the IND regulations.
Comments are due January 12, 2011
9/29/2010: Safety Reporting Requirements for INDs and BA/BE Studies, Guidance for Industry and Investigators (Draft) (PDF - 688KB)
This document provides guidance to sponsors and investigators on safety reporting requirements for human drug and biological products that are being investigated under an investigational new drug application (IND) and for drugs that are the subjects of bioavailability (BA) and bioequivalence (BE) studies that are exempt from the IND requirements. This guidance contains definitions used for safety reporting, makes recommendations on when and how to submit a safety report, and provides advice on other safety reporting issues that have generated questions from sponsors and investigators.
Comments are due December 28, 2010.
2/19/2010: Proposed rule - Reporting Information Regarding Falsification of Data
The proposed rule will require sponsors to report information indicating that any person has, or may have, engaged in the falsification of data involving studies including, but not limited to, clinical investigations, nonclinical laboratory studies, and clinical studies in animals.
Comments are due May 20, 2010.
1/13/2010: IRB Continuing Review After Clinical Investigation Approval, Draft Guidance (PDF - 244 KB)
This guidance is intended to assist IRBs in carrying out their continuing review responsibility under 21 CFR 56.108(a) and 56.109(f) by providing recommendations regarding the criteria, process, and frequency of continuing review to assure the protection of the rights and welfare of subjects in clinical investigations. The draft guidance should also help clinical investigators and sponsors better understand their responsibilities related to continuing review.
Comments are due March 15, 2010.
Written or electronic comments on this draft guidance will be accepted until March 5, 2007.
1/17/06: Withdrawal of the Advance Notice of Proposed Rulemaking entitled "Institutional Review Boards: Requiring Sponsors and Investigators to Inform Institutional Review Boards of Any Prior Institutional Review Boards Reviews"
After reviewing public comments on this ANPRM, FDA concluded that rulemaking on this matter was not warranted at this time. A notice withdrawing this ANPRM published in the Federal Register on Jan. 16, 2006. This notice can be found on FDA's Dockets Management Web site at www.accessdata.fda.gov/scripts/oc/ohrms/frbydocket.cfm.
The effective date for this withdrawal is February 16, 2006.
PDF version of the draft guidance
FDA is revising its March 2002 guidance for industry of the same title to include guidance for sponsors who will be submitting information required by the Best Pharmaceuticals for Children Act. Written comments should be submitted to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Room 1061, Rockville, MD 20852. Electronic comments for Docket No. 2004D-0014 must be submitted by March 29, 2004.
