Science & Research

Proposed Regulations and Draft Guidances

9/20/2018: Draft Guidance: Civil Money Penalties Relating to the Data Bank

The Food and Drug Administration has issued the draft guidance titled "Civil Money Penalties Relating to the Data Bank."  The guidance is intended for FDA staff, responsible parties, and submitters of certain applications and submissions to FDA.

This guidance document is intended to describe the current thinking of FDA regarding civil money penalties under section 303(f)(3) of the Federal Food, Drug, and Cosmetic Act (FD&C Act). That section authorizes FDA to assess civil money penalties against responsible parties and/or submitters of certain applications and submissions to FDA regarding drug products, biological products, and device products who violate applicable FD&C Act prohibitions relating to requirements under section 402(j) of the Public Health Service Act (42 U.S.C. 282(j)), including its implementing regulations in 42 CFR Part 11, to submit registration and/or results information to the data bank and/or certain certifications to FDA.
Comments due by November 20, 2018

04/09/2018:  Draft Guidance - Pregnant Women: Scientific and Ethical Considerations for Inclusion in Clinical Trials

This draft guidance discusses the ethical and scientific issues when considering the inclusion of pregnant women in clinical trials of drugs and biological products. This draft guidance is intended to advance scientific research in pregnant women, and discusses issues that should be considered within the framework of human subject protection regulations.
Comments are due by June 8, 2018.

6/21/2017: Draft Guidance: Use of Electronic Records and Electronic Signatures in Clinical Investigations Under Part 11- Questions and Answers

This draft guidance provides recommendations to sponsors, clinical investigators, IRBs, CROs, and other interested parties on the use of electronic records and electronic signatures under part 11 in clinical investigations of medical products. The draft guidance clarifies, updates, and expands upon recommendations in the 2003 part 11 guidance for recommendations that pertain to FDA-regulated clinical investigations conducted under parts 312 and 812. Thus, the guidance is limited to the scope and application of part 11 requirements to such clinical investigations.

The goals of the draft guidance are to clarify and update recommendations for applying and implementing part 11 requirements in the current environment of electronic systems used in clinical investigations and to encourage and facilitates the use of electronic records and systems to improve the quality  and efficiency of clinical investigations.

The guidance discusses the procedures that may be followed to help ensure that electronic records and electronic signatures meet FDA requirements and are considered to be trustworthy, reliable, and generally equivalent to paper records and handwritten signatures executed on paper. The guidance also discusses the use of a risk-based approach when deciding to validate electronic systems, implement audit trails for electronic records, and archive records that are pertinent to clinical investigations conducted under parts 312 and 812.
Comments due by August 21, 2017.

04/22/2015: Acceptance of Medical Device Clinical Data from Studies Conducted Outside the United States - Draft Guidance for Industry and Food and Drug Administration Staff

This draft guidance focuses on FDA’s policy of accepting scientifically valid clinical data from foreign clinical studies in support of premarket submissions for devices. The guidance describes special considerations that apply when using such data, including applicability of the data to intended patient populations within the United States and study design issues, and also provides recommendations to assist sponsors in developing data that are adequate under applicable FDA standards to support approval or clearance of the device in the United States.
Comments due by July 20, 2015.

07/15/2014: Informed Consent Information Sheet Guidance for IRBs, Clinical Investigators, and Sponsors (Draft)

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.

3/18/2014: Draft guidance: Humanitarian Device Exemption (HDE): Questions and Answers

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.

5/9/2013: Draft Guidance: Charging for Investigational Drugs Under an IND - Q&As

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

5/9/13: Draft Guidance: Expanded Access to Investigational Drugs for Treatment Use - Q&As

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

2/25/2013: Proposed Rule: Human Subject Protection; Acceptance of Data From Clinical Studies for Medical Devices

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.

12/17/2012: Draft Guidance for Industry Enrichment Strategies for Clinical Trials to Support Approval of Human Drugs and Biological Products

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

11/20/2012: Guidance for Industry Electronic Source Data in Clinical Investigations

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.

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.

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

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

11/28/06: FDA Extends the Comment Period on the Draft Guidance for Industry, Clinical Laboratories and FDA Staff on In Vitro Diagnostic Multivariate Index Assays [PDF107 KB]

Federal Register Notice.

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

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"

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.

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