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.
This guidance provides recommendations for clinical investigators, sponsors, and institutional review boards (IRBs) on the use of electronic media and processes to obtain informed consent for FDA-regulated clinical investigations of medical products, including human drug and biological products, medical devices, and combinations thereof.
Comments due by May 8, 2015
This draft guidance is intended to assist IRBs, clinical investigators, and sponsors involved in clinical investigations of FDA-regulated products in carrying out their responsibilities related to informed consent. The guidance provides the Agency’s recommendations and requirements for informed consent to assure the protection of the rights and welfare of human subjects in clinical investigations. This guidance describes the basic and additional elements of informed consent and includes topics such as review of patient records, children as subjects, and subject participation in more than one study.
The comment period for the draft guidance published July 25, 2014 is extended. Comments will be received through October 27, 2014.
This draft guidance answers commonly asked questions about Humanitarian Use Devices (HUDs) and the Humanitarian Device Exemption (HDE) authorized under section 520(m) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act). Section 613 of the Food and Drug Administration Safety and Innovation Act (FDASIA) (Pub. L. 112-144), signed into law on July 9, 2012, amended section 520(m) of the FD&C Act. This guidance document also reflects changes in the HDE program resulting from FDASIA.
Comments due by May 19, 2014.
This draft guidance is intended to provide information for industry, researchers, and physicians about the implementation of FDA’s regulation on charging for investigational drugs under an Investigational New Drug Application (IND) (21 CFR 312.8), which went into effect on October 13, 2009. It includes information concerning charging for investigational drugs made available under expanded access programs.
Comments are due by July 8, 2013
This draft guidance is intended to provide information for industry, researchers, physicians, and patients about the implementation of FDA’s regulations on expanded access to investigational drugs for treatment use under an investigational new drug application (IND) (21 CFR part 312, subpart I), which went into effect on October 13, 2009.
Comments are due by July 8, 2013
The Food and Drug Administration (FDA) is proposing to amend its regulations on acceptance of data from clinical studies for medical devices. We are proposing to require that clinical studies conducted outside the United States as support for an investigational device exemption (IDE) application, a premarket notification (510(k)) submission, a premarket approval (PMA) application, a product development protocol (PDP) application, or a humanitarian device exemption (HDE) application be conducted in accordance with good clinical practice (GCP), which includes obtaining and documenting the review and approval of the study by an independent ethics committee (IEC) and obtaining and documenting freely given informed consent of study subjects. The proposed rule is intended to update the standards for FDA acceptance of data from clinical studies conducted outside the United States and to help ensure the protection of human subjects and the quality and integrity of data obtained from these studies. As part of this proposed rule, we are also proposing to amend the IDE and 510(k) regulations to address the requirements for FDA acceptance of data from clinical studies conducted inside the United States. The proposed amendments are intended to provide consistency in FDA requirements for acceptance of clinical data, whatever the application or submission type.
Comments are due by May 28, 2013.
This document provides guidance to industry on enrichment strategies that can be used in clinical trials intended to support effectiveness and safety claims in new drug applications (NDAs) and biologics license applications (BLAs). Similar strategies may also be useful in studies conducted in earlier stages of development.
Comments are due by February 15, 2013
This draft guidance document provides recommendations to sponsors, Contract Research Organizations (CROs), data management centers, clinical investigators, and others involved in capturing, reviewing, and archiving electronic source data in FDA-regulated clinical investigations. This draft guidance document promotes capturing source data in electronic form, and it is intended to assist in ensuring the reliability, quality, integrity, and traceability of electronic source data.
Comments are due by January 22, 2013
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.
8/15/2011: 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
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
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.
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.
1/27/04--FDA published a Notice of Availability announcing the availability of a draft guidance entitled "Information Program on Clinical Trials for Seriousor Life-Threatening Diseases and Conditions"
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.